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Aug 5, 2009
08/09
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fda does not have subpoena power, but any fda inspector has the authority to obtain records inspection by visiting the company, and they can demand any form of record relating to information on safety and effectiveness in the files of the company. they have 100% of 42 obtain them. this is extremely important, it is a violation regarded by the fda as the most serious violation if a company that fails to submit all of the relevant safety and effectiveness information as part of their p.m. a, when i was chief counsel, i can assure you the one area i always considered criminal sanctions was the failure of our company to report things they were required to report, either with the original application for after a drug or device was marketed, when there are also reporting requirements. the fda's criminal authorities is the strongest criminal authority under any federal statutes. it does not require knowledge or intent by the company or the individual. it is what we call strict
fda does not have subpoena power, but any fda inspector has the authority to obtain records inspection by visiting the company, and they can demand any form of record relating to information on safety and effectiveness in the files of the company. they have 100% of 42 obtain them. this is extremely important, it is a violation regarded by the fda as the most serious violation if a company that fails to submit all of the relevant safety and effectiveness information as part of their p.m. a, when...
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Aug 5, 2009
08/09
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and even companies ignore fda? s-540 fosters distrust and disrespect for fda decisions and undermines the public health protection that the pma system is intended to provide. sixth, product liability awards punish companies. there's no question about that. but they do not in any way contribute to safer or more effective pma devices. it is the inevitable adverse events that we know will always occur with a device that lead fda and companies to correct deficiencies and improve the device. but by the time a lawsuit is brought and completed, the problem has been corrected and the safety issue has been resolved to the extent that it can be. if it's not inherent in the device. finally, i fully support compensation of people injured by pma devices. there's no question about that. but the solution is not to farm out fda decisions to juries throughout the country. the answer is not to replace national uniformity with national inconsistency and regulatory chaos. the jury system is nothing short of a lottery. some plaintiffs
and even companies ignore fda? s-540 fosters distrust and disrespect for fda decisions and undermines the public health protection that the pma system is intended to provide. sixth, product liability awards punish companies. there's no question about that. but they do not in any way contribute to safer or more effective pma devices. it is the inevitable adverse events that we know will always occur with a device that lead fda and companies to correct deficiencies and improve the device. but by...
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Aug 8, 2009
08/09
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and even companies ignore fda? s-540 fosters distrust and disrespect for fda decisions and undermines the public health protection that the pma system is intended to provide. sixth, product liability awards punish companies. there's no question about that. but they do not in any way contribute to safer or more effective pma devices. it is the inevitable adverse events that we know will always occur with a device that lead fda and companies to correct deficiencies and improve the device. but by the time a lawsuit is brought and completed, the problem has been corrected and the safety issue has been resolved to the extent that it can be. if it's not inherent in the device. finally, i fully support compensation of people injured by pma devices. there's no question about that. but the solution is not to farm out fda decisions to juries throughout the country. the answer is not to replace national uniformity with national inconsistency and regulatory chaos. the jury system is nothing short of a lottery. some plaintiffs
and even companies ignore fda? s-540 fosters distrust and disrespect for fda decisions and undermines the public health protection that the pma system is intended to provide. sixth, product liability awards punish companies. there's no question about that. but they do not in any way contribute to safer or more effective pma devices. it is the inevitable adverse events that we know will always occur with a device that lead fda and companies to correct deficiencies and improve the device. but by...
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Aug 13, 2009
08/09
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i do have a few questions of the fda. one discretion is in the case of a chemical substance, added to plastics to change their physical characteristics. the fda has yet to establish a standard for this contaminant and bottled water. an fda task force is supposedly examining the information surrounding the chemical, and i want to ask the commissioner when we can expect a ruling from your agency. the question is about recycled bottles themselves. i have had some tall made that the use of recycled bottles perhaps produces more leeching that comes out of the plastic than first time used. conducting inspections is one way that the fda is insuring that they are following restrictions. i would be curious to know the legislation passed unanimously out of the full committee that expands fda's inspection process. i would like to hear from the deputy commissioner as well on how the agency can prove the inspection process and if you need additional authorities. congress needs to act and we need to know what the agency needs to comply
i do have a few questions of the fda. one discretion is in the case of a chemical substance, added to plastics to change their physical characteristics. the fda has yet to establish a standard for this contaminant and bottled water. an fda task force is supposedly examining the information surrounding the chemical, and i want to ask the commissioner when we can expect a ruling from your agency. the question is about recycled bottles themselves. i have had some tall made that the use of recycled...
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Aug 5, 2009
08/09
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i'm just concerned about the fda. i've been concerned about the fda for a long time. i have a love/hate relationship with the fda. i can tell you that. sometimes they do good things. other times they don't do what they should be doing. more often than not, it's because we have not given them the resources with which to do it. and i kind of interjected, even when mr. hutt was speaking. i don't mean we don't want to give them. we should give them the resources. we've asked them to do a myriad of things. and yet we don't give them the resources to carry it out. so count me as one that also believes we ought to do more in terms of giving the fda those resources. i just think under the present budget resources and stuff like that, it's probably not going to happen. >> did anyone have any final comment? i think we're now starting to vote. i have to go vote. you'll set a new land speed record? >> yes, sir. friday and saturday. >> so you'll break the sound barrier? >> not the sound barrier. in our class, about 170 miles an hour. >> i don't know what class this is. >> differen
i'm just concerned about the fda. i've been concerned about the fda for a long time. i have a love/hate relationship with the fda. i can tell you that. sometimes they do good things. other times they don't do what they should be doing. more often than not, it's because we have not given them the resources with which to do it. and i kind of interjected, even when mr. hutt was speaking. i don't mean we don't want to give them. we should give them the resources. we've asked them to do a myriad of...
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Aug 5, 2009
08/09
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fda is not perfect. but certainly a jury is going to be less perfect in determinism what is a safe and effective medical device. >> the very best devices we can to help people like mr. mulvihill, like mr. roman, in ways they have got to be helped. we have split the baby here. is that a fair appraisal? >> i agree with you. one of the best parts of the medical device amendment of 1976 was an innovative provision under which advisory committees would be convened for every p.m. a device to make certain outside independent experts agree with the fda that the device was safe and effective, and dr. maisel, who has chaired one of those committees and obviously has spent a lot of personal time for which all of us should thank him, it is that kind of work that makes the system work. that is the way the fda confirms whether a device is safe and effective and has sufficient data to go on the market. >> mr. mcgarity, part of your testimony, you argue that the common law serves an important terms function, specificall
fda is not perfect. but certainly a jury is going to be less perfect in determinism what is a safe and effective medical device. >> the very best devices we can to help people like mr. mulvihill, like mr. roman, in ways they have got to be helped. we have split the baby here. is that a fair appraisal? >> i agree with you. one of the best parts of the medical device amendment of 1976 was an innovative provision under which advisory committees would be convened for every p.m. a device...
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Aug 1, 2009
08/09
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fda is committed to ensuring that the u.s. food supply continues to be among the safest in the world. president obama has made a personal commitment to improving food safety. on july 7th, this year, the multiagency food safety working group that the president established issued its key findings on how to upgrade the food safety system for the 21st century. they recommend a new public health focus approach to food safety based on three core principles. prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery. fda has been an integral park of the working group's continuing efforts to establish these principles. fresh produce, the topic of today's hearing, presents special safety challenges, as the chairman outlined. a number of illnesses associated with fresh produce is a continuing concern for fda. the increased consumption of produce in its presh or raw form including ready-to-eat bagged products reflects growing consumer interest in healthy eating, which you indicated, which is,
fda is committed to ensuring that the u.s. food supply continues to be among the safest in the world. president obama has made a personal commitment to improving food safety. on july 7th, this year, the multiagency food safety working group that the president established issued its key findings on how to upgrade the food safety system for the 21st century. they recommend a new public health focus approach to food safety based on three core principles. prioritizing prevention, strengthening...
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no problems related to using the products have been reported to the fda. clarcon voluntarily recalled in june. the fda says the company failed to follow protocols that could've prevented the contamination. >>> in canada, a stage collapsed in the middle of an outdoor music festival. police say one person was killed and 15 other people were injured at the big valley jamboree in alberta. a storm quickly rolled in while some 15,000 people were watching the festival yesterday. the crowd started to evacuate and that's when the stage came down. police say emergency services helped rescue some people trapped under the rubble. >>> president obama's economic recovery plan focussed on shovel-ready projects to put people back to work. but it's also giving people jobs. people who never touch a shovel. see how the money is helping fight crime on hln news and views. >>> 31 toledo police officers laid off because of budget cuts are getting their jobs back. the city's using a grant from the federal economic recovery program to pay for the return. toledo is also getting ano
no problems related to using the products have been reported to the fda. clarcon voluntarily recalled in june. the fda says the company failed to follow protocols that could've prevented the contamination. >>> in canada, a stage collapsed in the middle of an outdoor music festival. police say one person was killed and 15 other people were injured at the big valley jamboree in alberta. a storm quickly rolled in while some 15,000 people were watching the festival yesterday. the crowd...
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the fda is warning people not to use clarcon skin products. no problems were related to using the products have been reported to the fda. clarcon voluntarily recalled the products in june. the fda says the company failed to follow protocols that could have prevented the contamination. >>> a kentucky man faces a murder charge in the death of a triathlon competitor. according to police, yates sped away from the scene and took off again after he was stopped by an off duty officer. his mother took yates back to the crash site, where he was arrested. >>> a teenager who was in and out of a coma for two months is finally home. a car accident nearly killed her. we find out what happened when she was in the hospital and will stay with her family forever. >> reporter: a sea of green shirts, bracelets, balloons, shoes, even bandannas waited for 30 minutes saturday to hug 16-year-old sequoia smith. >> i feel awesome. >> i'm so excited. >> but in reality, the so-called green team has been waiting three months for sequoia to come home. >> it was very fright
the fda is warning people not to use clarcon skin products. no problems were related to using the products have been reported to the fda. clarcon voluntarily recalled the products in june. the fda says the company failed to follow protocols that could have prevented the contamination. >>> a kentucky man faces a murder charge in the death of a triathlon competitor. according to police, yates sped away from the scene and took off again after he was stopped by an off duty officer. his...
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Aug 22, 2009
08/09
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on the tight end bring to the cost of the fda. i would like to hear your comments on that. >> most of the complaints i hear, the fda doesn't include drugs more quickly. i believe we have tried to respond to that issue by in some cases accelerating approvals where appropriate. secondly, we have the problem of what is called orphan drugs, drugs made for swine flu. the other thing you have are certain drugs in immunizations. other people with adverse reactions but the lawsuit could be enormous. one of the questions is did we go too far. those who question quality numbers of supplements the argument a lot of the time with athletes. i'm not an absolute defender of the fda we do a pretty good job. one of the issues thatúpy usual comes up is what people say what with about ge far rick. you want people to use their ability of coming up with new ideas we want to make sure we have people that are a benefit. they have an exclusive right to that which they came up with. we had a problem years ago where we saw the fda take a while to approve
on the tight end bring to the cost of the fda. i would like to hear your comments on that. >> most of the complaints i hear, the fda doesn't include drugs more quickly. i believe we have tried to respond to that issue by in some cases accelerating approvals where appropriate. secondly, we have the problem of what is called orphan drugs, drugs made for swine flu. the other thing you have are certain drugs in immunizations. other people with adverse reactions but the lawsuit could be...
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Aug 8, 2009
08/09
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and i'm i am just concerned about the fda. i have a love-hate relationship with the fda, i can tell you that. sometimes they do good things, and other times they do not know what -- they do not do what they should be doing. more often than not, it is because we have not given them the resources with which to do it. i do not mean that we do not want to give them, we should give them the resources. we have asked them to do a myriad of things, and yet we do not give them the resources to carry it out. out. so count me as one that also believes we ought to do more in terms of giving the fda those resources. i just think under the present budget resources and stuff like that, it's probably not going to happen. >> did anyone have any final comment? i think we're now starting to vote. i have to go vote. you'll set a new land speed record? >> yes, sir. friday and saturday. >> so you'll break the sound barrier? >> not the sound barrier. in our class, about 170 miles an hour. >> i don't know what class this is. >> different cars run at
and i'm i am just concerned about the fda. i have a love-hate relationship with the fda, i can tell you that. sometimes they do good things, and other times they do not know what -- they do not do what they should be doing. more often than not, it is because we have not given them the resources with which to do it. i do not mean that we do not want to give them, we should give them the resources. we have asked them to do a myriad of things, and yet we do not give them the resources to carry it...
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>> this former zicam user praises the fda's warning but says it has come too late for him. he fears his sense of smell may never return. >> it's very angering. >> michael flynn, news 4. >> now, again, the marekor make zicam voluntariry li recalled the products but the company insists the products are safe. >>> it's a document but as controversial as its subject. the nine lives of marion barry closed out the film festival in our area. derrick ward talked about the story behind putting it on the screen. >> it's a story most of us would say we already know, but who pro-deucers of the documentary entitled "the nine lives of marion barry," say as closely as he's scrutinized, there are sides of his life we have never seen. >> want to make this film for outside of washington. washington is included, but we waed to show there's so much more to his story. >> the producers had unprecedented access covering his last campaign for city council. for the producers, it was a learning experience. >> as filmmakers you try to crawl into the mind of someone and blend into the woodwork. that wa
>> this former zicam user praises the fda's warning but says it has come too late for him. he fears his sense of smell may never return. >> it's very angering. >> michael flynn, news 4. >> now, again, the marekor make zicam voluntariry li recalled the products but the company insists the products are safe. >>> it's a document but as controversial as its subject. the nine lives of marion barry closed out the film festival in our area. derrick ward talked about...
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Aug 25, 2009
08/09
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why the fda says alli may do more harm than good. that's next in the health check. >>> and pop star joins the explain. oh yea, well for 6 months, customers get all three: fios tv, internet and phone for just $79.99 a month. oh, alright, see... you're just moving your fingers, aren't you? i gotta cut my nails. (announcer) now get three amazing fios services for the price of two. tv, internet, and phone for only $79.99 a month for 6 months. plus a free multi-room dvr for three months. record shows in one room--watch in another. call the verizon center for customers with disabilities at 800.974.6006 tty/v and get fios tv - ranked highest in overall customer satisfaction by j.d. power and associates. america's top rated internet--now even faster, and crystal clear phone service. all for just $79.99 a month for 6 months. plus, for a limited time, a free multi-room dvr for 3 months. that's an overall savings of $240 dollars over six months. don't miss this unbeatable value 3 great services, for the price of 2. call the verizon center for c
why the fda says alli may do more harm than good. that's next in the health check. >>> and pop star joins the explain. oh yea, well for 6 months, customers get all three: fios tv, internet and phone for just $79.99 a month. oh, alright, see... you're just moving your fingers, aren't you? i gotta cut my nails. (announcer) now get three amazing fios services for the price of two. tv, internet, and phone for only $79.99 a month for 6 months. plus a free multi-room dvr for three months....
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Aug 9, 2009
08/09
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that is the test that fda, try to control substance, a drug. but the real question is how hard, motivation, how hard will and animal work. would you do is make an animal pressed the level once, give him food, press applies and then you give him food, and then they have to press for times and then they have to press 16 times and then 32 times, 64 times 120 times before they get food. so you have a sense of what the breakpoint is. what do you think they will work hardest for? the answer was, it was sugar. sugar was the main driver. but when you add to that sugar, you at that. it is synergistic pick it is more. second piece of science. with my colleagues in italy, one of the great pharmacologists, he has dedicated his career to understanding how drugs hijack the brain. he studies amphetamines, he studies cocaine's. and the window is when you administer drugs like amphetamines and cocaine, what you see is bumps in the brain circuitry involving dopamine. every time you give amphetamines or cocaine you see this elevation in the brains dopamine and th
that is the test that fda, try to control substance, a drug. but the real question is how hard, motivation, how hard will and animal work. would you do is make an animal pressed the level once, give him food, press applies and then you give him food, and then they have to press for times and then they have to press 16 times and then 32 times, 64 times 120 times before they get food. so you have a sense of what the breakpoint is. what do you think they will work hardest for? the answer was, it...
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Aug 16, 2009
08/09
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the agency says the products change time and critics accuse the fda of dragging its feet. >> chances are you if you didn't buy sunscreen. >> won't know what you are purchasing. there is no such thing as all- day protection. the proposed labeling changes would put a cap on claims by manufacturers. currently they can claim a sun protection factor of 80, 90 and even 100, but experts say a rating of 50 is about the most protection that consumers can expect. the new rating system would inform users about the specific type of protection they are purchasing. current spf ratings are only for uvb protection. those are the rays that cause us to burn. but under the proposed changes, sunscreen labeling would have a star system, to reveal the level of protection against uva, those are the rays that cause tanning but that experts could be most dangerous. and next time you take a dip in the pool, consider this -- >>he new fda rulings will eliminate the word waterproof and only allow for water resistent or highly water resistent. >> reporter: so when will the changes take place? the boast hope is by
the agency says the products change time and critics accuse the fda of dragging its feet. >> chances are you if you didn't buy sunscreen. >> won't know what you are purchasing. there is no such thing as all- day protection. the proposed labeling changes would put a cap on claims by manufacturers. currently they can claim a sun protection factor of 80, 90 and even 100, but experts say a rating of 50 is about the most protection that consumers can expect. the new rating system would...
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Aug 17, 2009
08/09
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critics accused fda of dragging its feet. >> the delay and indecision on the part of the fda is absolutely inexcusable and unconscionable. >> reporter: chances are, if you ever bought sunscreen, you didn't know what type of protection you were purchasing. for example, experts say despite claims, there is such thing as all-day protection. the proposed fda labeling changes would put a cap on claims by manufacturers. currently, sunscreens can claim an spf of 80, 90, even 100. experts say a rating of 50 is about the most protection consumercan expect. the new rating system would also inform sunscreen users about the specific type of protection they are purchasing. current spf ratings are only for uvb protection. those are the rays that cause us to burn. but under the proposed changes, sun serena labeling would have a star system to reveal the level of protection against uva. those are the rays that cause tanning but experts believe could be most dangerous. the next time you take a dip in the pool, consider this. >> the new fda rulings will eliminate the word waterproof and only allow for water
critics accused fda of dragging its feet. >> the delay and indecision on the part of the fda is absolutely inexcusable and unconscionable. >> reporter: chances are, if you ever bought sunscreen, you didn't know what type of protection you were purchasing. for example, experts say despite claims, there is such thing as all-day protection. the proposed fda labeling changes would put a cap on claims by manufacturers. currently, sunscreens can claim an spf of 80, 90, even 100. experts...
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Aug 4, 2009
08/09
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> each of the supplements go back to the fda consideration. supplements often do not require human clinical testing. you are now looking at at least 15 years removed from the are original. there is not a lot of clinical data that was submitted. the idea it will function perfectly well and the manufacturer will not be liable is an interesting policy. >> thank you. >> do you have any comment about anything similar? >> it supplemental pma required for any change of any kind and is required to be approved by fda using the same standards of safety and effectiveness as the original pma > i do not want there to be any confusion about theiat. they look at the entire document. there is no distinction between the original and the supplemental pma. the fda in this instance, perhaps incorrectly, what they did was look at all the data on safety and effectiveness in humans. they concluded that the new lead did not require additional human data. i am not a scientist. i cannot say they were right or they were wrong. the doctors more qualified than i to make t
> each of the supplements go back to the fda consideration. supplements often do not require human clinical testing. you are now looking at at least 15 years removed from the are original. there is not a lot of clinical data that was submitted. the idea it will function perfectly well and the manufacturer will not be liable is an interesting policy. >> thank you. >> do you have any comment about anything similar? >> it supplemental pma required for any change of any kind...
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Aug 17, 2009
08/09
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fda has been working on it two years now. no word on when it will take effect. >>> a haircut for a good cause. how this fund-raiser is helping hundreds of very special students. the stories still to come. >>> good evening, ladies and gentlemen. looking at a pretty warm weekend with plenty of sunshine. looks like we're going to see things heating up as we go through the work week and we're going to continue to see chances for showers towards the middle of the week. looking outside right now, hd skycam inner harbor relatively quiet conditions. clear skies. temperatures right now sitting at 78 degrees. winds are calm and humidity levels at 71 percent. pressure at 30.71 inches. we'll continue to see that rise as high pressure moves into the area keeping us nice and clear the next couple of days. right now temperatures across the middle portions of the state, 82. baltimore look at 76 degrees. harrisburg. richmond looks like we'll continue to see the warm air back from the southwest start to wrap around the area of high pressure th
fda has been working on it two years now. no word on when it will take effect. >>> a haircut for a good cause. how this fund-raiser is helping hundreds of very special students. the stories still to come. >>> good evening, ladies and gentlemen. looking at a pretty warm weekend with plenty of sunshine. looks like we're going to see things heating up as we go through the work week and we're going to continue to see chances for showers towards the middle of the week. looking...
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based on the available data, the fda stated that for certain patients celebrex's benefits outweigh the risks. if you are worried about stomach upset, you should know, in clinical studies, a lower percentage of patients taking celebrex reported stomach discomfort versus prescription ibuprofen and naproxen. and if you are taking low-dose aspirin for your heart and need an nsaid pain reliever, celebrex can be used because it doesn't interfere with the effects of low-dose aspirin. but when it comes to relieving your arthritis pain, you and your doctor need to balance the benefits with the risks. the fda requires all prescription nsaids, including celebrex, ibuprofen, naproxen and meloxicam, to have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart disease or risk factors for it such as high blood pressure or when nsaids are taken for long periods. all prescription nsaids, including celebrex, also increase the chance of serious skin reactions or stomach and intestine problems, such as
based on the available data, the fda stated that for certain patients celebrex's benefits outweigh the risks. if you are worried about stomach upset, you should know, in clinical studies, a lower percentage of patients taking celebrex reported stomach discomfort versus prescription ibuprofen and naproxen. and if you are taking low-dose aspirin for your heart and need an nsaid pain reliever, celebrex can be used because it doesn't interfere with the effects of low-dose aspirin. but when it comes...
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Aug 3, 2009
08/09
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if you have any of these products the fda says throw them out. >>> it is monday. feeling like it an here. >> for me feels like a great day because we have not chasing a million storms. they have been violent with heavy rain. one storm tonight but most of us are having a lovely monday evening. >> it is running up the coast a little bit. >> there is a lot of stuff off the coast. we will are in tropical season. now we turned the calendar page in to august, kind of nice to get a break from the humidity but that soup will be back soon enough. get out and take a walk tonight and enjoy the lower humidity and increased visibility that we are seeing live as we look over northwest washington. here's what brian was talking about. we have a system, the weather front that passed us by and brought in refreshing air has stalled off the coast. we still have slow-moving thunderstorms off the carolinas to the virginia beach area. i will get in tighter and while there's not much to see on our live radar, if you look closely salisbury, i know you are seeing this thing. there is a thu
if you have any of these products the fda says throw them out. >>> it is monday. feeling like it an here. >> for me feels like a great day because we have not chasing a million storms. they have been violent with heavy rain. one storm tonight but most of us are having a lovely monday evening. >> it is running up the coast a little bit. >> there is a lot of stuff off the coast. we will are in tropical season. now we turned the calendar page in to august, kind of nice...
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Aug 26, 2009
08/09
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. >>> the fda has offered emergency use of the swine flu vaccine. the fda commissioner says the test will mean faster diagnoses for a sick servicemen and women. it authorizes the use of unapproved medical products during a declared public health emergency. >>> we know too much sugar is not a good thing. now the american heart association is providing recommendations for consumption of food when sugar has been added. >> the love affair with sugar is not so sweet when considering the potentially dangerous impact on health. >> obesity is practically an epidemic, and it is almost calls for a lot of the diseases, especially heart disease. >> americans consume 22 teaspoons of sugar a day. that equals two cans of soda and a chocolate bar. the heart association says that is too much and recommends a decrease in sugar intake. for women, 100 calories a day and four men come out 150 calories. >> -- and for men, 150 calories a day. >> sugar and other sweeteners are added to many traits but to frozen dishes, cereal and other foods. -- they are added to many food
. >>> the fda has offered emergency use of the swine flu vaccine. the fda commissioner says the test will mean faster diagnoses for a sick servicemen and women. it authorizes the use of unapproved medical products during a declared public health emergency. >>> we know too much sugar is not a good thing. now the american heart association is providing recommendations for consumption of food when sugar has been added. >> the love affair with sugar is not so sweet when...
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Aug 17, 2009
08/09
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the situation with the fda is labeling the products. now another summer has gone by without changes. the critics say the process takes time, others use the fda of dragging their feet. >> the delay is just not excusable. >> reporter: chances are if you ever bought sunscreen you didn't know the type of protection you purchased. for example, experts say despite claims there is not an all-day protection. they propose that putting a label on it could help the manufacturers. curntly sunscreens can claim an spf, sun protection of 180 or 90 or 100. but they say you can only expect a certain amount. it would inform people about the specific type of protection they're purchasing. the current ratings are only for certain ray protection, the ones that cause us to burn. but under the proposed changes, the sunscreen label would have a star system to show the protection against the raysment s. they are the ones that cause tanning. and next time you take a dip in the pool, cosider this. >> the new fda labels will eliminate the word water-proof, and onl
the situation with the fda is labeling the products. now another summer has gone by without changes. the critics say the process takes time, others use the fda of dragging their feet. >> the delay is just not excusable. >> reporter: chances are if you ever bought sunscreen you didn't know the type of protection you purchased. for example, experts say despite claims there is not an all-day protection. they propose that putting a label on it could help the manufacturers. curntly...
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326
Aug 13, 2009
08/09
by
WJLA
tv
eye 326
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the fda requires all prescription nsaids, including celebrex, ibuprofen, naproxen and meloxicam, to have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart disease or risk factors for it such ashi blood pressure or when nsaids are taken for long periods. all prescription nsaids, including celebrex, also increase the chane of serious skin reactions or stomach nd intestine problems,, such as bleeding and ulcers, which can occur without " warning and may cause death. patients also taking aspirin and the elderly are at increased risk for stomach bleeding and ulcers. do not take celebrex if you're allergic to aspirin or sulfonamides. ask your doctor if you could benefit from celebrex. understand the risks. eel the benefits. >> zbla bizarre emergency landing in las vegas. the pilot of a police helicopter forced to bring it down in the ddle of a city street after the engine suddenly failed. amazingly, no one was hurt the chopper missed power lines and light poles. it was fixed and ready to
the fda requires all prescription nsaids, including celebrex, ibuprofen, naproxen and meloxicam, to have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart disease or risk factors for it such ashi blood pressure or when nsaids are taken for long periods. all prescription nsaids, including celebrex, also increase the chane of serious skin reactions or stomach nd intestine problems,, such as...
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based on the available data, the fda stated that for certain patients celebrex's benefits outweigh the risks. if you are worried about stomach upset, you should know, in clinical studies, a lower percentage of patients taking celebrex reported stomach discomfort versus prescription ibuprofen and naproxen. and if you are taking low-dose aspirin for your heart and need an nsaid pain reliever, celebrex can be used because it doesn't interfere with the effects of low-dose aspirin. but when it comes to relieving your arthritis pain, you and your doctor need to balance the benefits with the risks. the fda requires all prescription nsaids, including celebrex, ibuprofen, naproxen and meloxicam, to have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart dease or risk factors for it such as high blood pressure or when nsaids are taken for long periods. all prescription nsaids, including celebrex, also increase the chance of serious skin reactions or stomach and intestine problems, such as b
based on the available data, the fda stated that for certain patients celebrex's benefits outweigh the risks. if you are worried about stomach upset, you should know, in clinical studies, a lower percentage of patients taking celebrex reported stomach discomfort versus prescription ibuprofen and naproxen. and if you are taking low-dose aspirin for your heart and need an nsaid pain reliever, celebrex can be used because it doesn't interfere with the effects of low-dose aspirin. but when it comes...
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Aug 15, 2009
08/09
by
WBAL
tv
eye 219
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according to the fda, those formulations can falsely elevate blood sugar levels. you can find more information on our website, wbaltv.com. >> today, president obama kicked off a poor state tour of its health care reform plan. he started off in belgrade montana or hundreds of people packed a town hall inside an airport hangar. the president answered some tough questions, including, which taxes be raised in order to pick the plan? >> i cannot cover another 46 million people for free. we do have to come up with that money. well as campaign, made a promise that i would not raise your taxes -- when i was campaigning, i made a promise i would not raise your taxes for those who may 200 the dozen dollars or less. for people to make a little bit more, there is nothing wrong with paying a little bit more. >> tomorrow marks the 40th anniversary of woodstock. it became a symbol of the '60s generation. this weekend, thousands are returning to the side to relive the music and the moments. ♪ >> richie havens perform his legendary song ago freedom" to kick off the 40 the annive
according to the fda, those formulations can falsely elevate blood sugar levels. you can find more information on our website, wbaltv.com. >> today, president obama kicked off a poor state tour of its health care reform plan. he started off in belgrade montana or hundreds of people packed a town hall inside an airport hangar. the president answered some tough questions, including, which taxes be raised in order to pick the plan? >> i cannot cover another 46 million people for free....
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Aug 29, 2009
08/09
by
WMAR
tv
eye 294
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unlike some other cholesterol .lowering medications,, lipitor is fda approved .to reduce the risk..., of heart attack, stroke, and certain kinds ! of heart surgeries... in patients with several common risk factors... or heart disease. lipitor has been extensively studied... with over 16 years of research. lipitor is not for everyone, including people with liver problems... and women who are nursing, pregnant, or may become pregnant. you need simple blood tests .to check for liver problems. tell your doctor if you are .taking other medications, or if you have any muscle pain or weakness. this may be a sign of a rare but serious side effect. i was caught off-guard. but maybe you can learn !from my story. have a heart to heart with your doctor... about your risk. and about lipitor. >>> tonight, california firefighters are battling several major wildfires. the worst, la canada in the mountains just north of los angeles. it's spreading rapidly in several directions. scores of homes have been evacuated. thick, acrid smoke is blanketing the sky for miles. public health officials are urging p
unlike some other cholesterol .lowering medications,, lipitor is fda approved .to reduce the risk..., of heart attack, stroke, and certain kinds ! of heart surgeries... in patients with several common risk factors... or heart disease. lipitor has been extensively studied... with over 16 years of research. lipitor is not for everyone, including people with liver problems... and women who are nursing, pregnant, or may become pregnant. you need simple blood tests .to check for liver problems. tell...
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Aug 22, 2009
08/09
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CSPAN
tv
eye 106
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tied with that, we have the fda. the people of this nation are being poorly served by the fda, an organization that approves drugs with little independent testing. it relies on tests paid for by the manufacturers themselves. it is not looking out for the best interest of all of us. the fda limits and seeks further control over natural remedies and substances which, in many instances, creates artificial drugs. it allows and encourages over inflated drug companies, and over inflated pricing of medicines. the fda needs to be reached in may -- recreated as a servant of this country. >> most of the complaints i hear, the fda does not improve drugs more quickly or quickly enough. i believe we have tried to respond to that issue by accelerating approvals were appropriate. secondly, drugs that are made for the flu, swine flu, that sort of thing. it may not be utilized if you happen to be -- happened to make the wrong choice. the government in some places subsidizes its. you also have some drugs that are necessary for immuniz
tied with that, we have the fda. the people of this nation are being poorly served by the fda, an organization that approves drugs with little independent testing. it relies on tests paid for by the manufacturers themselves. it is not looking out for the best interest of all of us. the fda limits and seeks further control over natural remedies and substances which, in many instances, creates artificial drugs. it allows and encourages over inflated drug companies, and over inflated pricing of...
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Aug 25, 2009
08/09
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WJZ
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eye 233
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alli is the only nonprescription weight loss drug approved by the fda. reports of teenagers abusing attention deficit disorder drugs are on the rise. costs soared 76% over an eight- year period ending in 2005. those calls came from parents, e.r. doctors and others, seeking advice on how to deal with the problem. the study does not indicate whether they were teenagers actually living with adhd, but it appears they were not. and a new warning about riding in the car with someone who smokes. new research shows passengers of smokers are exposed to nicotine levels. some medical experts are now questioning whether smoking should be banned in cars, as well as restaurants and bars. >> reporter: the report appears in today's edition of the online journal, "tobacco control." i'm kellye lynn with healthwatch. >> and they have at least a 30- minute round trip commute to work. >>> pipe bomb explosion. two blasts go off inside a crowded high school. who police say is responsible. >>> plane uncomfortable. one airline's recommendations that passengers say don't go far e
alli is the only nonprescription weight loss drug approved by the fda. reports of teenagers abusing attention deficit disorder drugs are on the rise. costs soared 76% over an eight- year period ending in 2005. those calls came from parents, e.r. doctors and others, seeking advice on how to deal with the problem. the study does not indicate whether they were teenagers actually living with adhd, but it appears they were not. and a new warning about riding in the car with someone who smokes. new...
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Aug 15, 2009
08/09
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WUSA
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the fda says certain blood sugar test strips can give inaccurate readings in patients that are taking other medications. the fda urges diabetes patients not to use these in combination with dialysis and other biologic drugs. >>> 40 years ago this week a relatively unknown band played their second gig together at a place called woodstock. tonight, minus neil young, crosby steels & nash performed. ♪[ music ] >> reporter: it was a sold out show. crosby steels & nash were back on the map. ♪[ music ] >> reporter: the fact that it was the 40th anniversary of woodstock was not lost on this crowd. some of which were part of the woodstock nation. >> i was at woodstock. it was amazing. it was the greatest music, the greatest spectacle i have ever seen. >> pulled up in his big convertible saying i'm going upstate for a big concert. upstate new york for three days and we turned it down and have been kicking ourselves in the butt ever since. >> the event guy said it is a free concert. and then it was just people. more people than i had ever seen in one place in my life. >> reporter: and what w
the fda says certain blood sugar test strips can give inaccurate readings in patients that are taking other medications. the fda urges diabetes patients not to use these in combination with dialysis and other biologic drugs. >>> 40 years ago this week a relatively unknown band played their second gig together at a place called woodstock. tonight, minus neil young, crosby steels & nash performed. ♪[ music ] >> reporter: it was a sold out show. crosby steels & nash were...
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Aug 3, 2009
08/09
by
WTTG
tv
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no cases have been reported to the fda. the fda seized the leftover items. >>> and time right now, 8:26 on monday morning, coming up next half hour, this week's money monday session. we'll check out more stories making head lines and that's including latest on a robbery of a 99-year-old woman in maryland. when verizon bri ngs 100% fibee it also brings first-class entertainment, with picture quality pc world calls "razor sharp," america's top-rated internet and crystal clear phone, all for just $79.99 a month for the first six months. you can also get channel variety cable can't match. plus, additional packages are available with over 115 hd channels and over 15,000 titles on demand per month. what else does fios bring that cable doesn't? how about easy-to-use on screen widgets that offer instant updates on local traffic, news, weather and more call the verizonenter for customers with disabilities at 800-974-6006 tty/v today to order fios tv, internet and phone for just $79.99 a month for the first six months. that's like ge
no cases have been reported to the fda. the fda seized the leftover items. >>> and time right now, 8:26 on monday morning, coming up next half hour, this week's money monday session. we'll check out more stories making head lines and that's including latest on a robbery of a 99-year-old woman in maryland. when verizon bri ngs 100% fibee it also brings first-class entertainment, with picture quality pc world calls "razor sharp," america's top-rated internet and crystal clear...
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Aug 22, 2009
08/09
by
CSPAN
tv
eye 179
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it was aided by the fact that the fda had more or less hunted down the case to join this majority, and i will say more about that in a minute. the argument is there is no conflict pre-emption of state failure to warn a claim just because the fda approved labeling. justice thomas wrote an interesting concurrence. he said, i do not really believe in it implied pre-emption. if congress wants to expressly preempt state law, it can say so. justice thomas does not believe in applied anything. he does not leave applied constitutional rights, so it is no surprise that he says no implied pre-emption. that means there is an ever- narrower speed spot to try and get five votes on the court. in the descent, they would have upheld pre-emption. it was interesting, because they are strict constructionists. but they were willing to have a more capacious view of pre- emption. just a little bit briefly, the claim was here that advertising of light cigarettes and reduced tar and nicotine were misleading, and addicted smokers went to town with to law, tried to practice. the court again found no preemptions
it was aided by the fact that the fda had more or less hunted down the case to join this majority, and i will say more about that in a minute. the argument is there is no conflict pre-emption of state failure to warn a claim just because the fda approved labeling. justice thomas wrote an interesting concurrence. he said, i do not really believe in it implied pre-emption. if congress wants to expressly preempt state law, it can say so. justice thomas does not believe in applied anything. he does...
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so far no problems related to using the products have been reported to fda. voluntarily recalled effective products back in june. >>> cuba's president telling u.s. forts about political change on the island. president castro rescued parliament yesterday. he said cuba is ready to start talking to the united states but the political system is not up for discussion. the obama administration meanwhile said it wants to see signs of change before it starts talking to cuba. >>> checking your forecast on this first sunday in august. for folks on the east coast, a little stormy. reynolds wolf for all the details. >> you're absolutely right. it's the eastern seaboard under the bull's eye. chance of severe storms mainly large hail and perhaps places like philadelphia, maybe over into new york before the day is over. and as we get to the afternoon hours, could be anywhere from nation's capital as far south as charleston. meanwhile back to the west and midwest could see reports in parts of south dakota and into portions of southern minnesota benefactor day is out. when yo
so far no problems related to using the products have been reported to fda. voluntarily recalled effective products back in june. >>> cuba's president telling u.s. forts about political change on the island. president castro rescued parliament yesterday. he said cuba is ready to start talking to the united states but the political system is not up for discussion. the obama administration meanwhile said it wants to see signs of change before it starts talking to cuba. >>>...
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Aug 16, 2009
08/09
by
FOXNEWS
tv
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. >> that is this point, the fda is this point person, and this fda is not involved now and now only pharmacies are involved and to get this fda involved, gregg, you use the data to benefit patients and if the drug is doing what people say it is or side effects people are not considering, once a drug is enforced -- approved there are not a lot of studies after that and it is a vast amount of data, as long as it is used properly. >> gregg: should there be a block on pharmaceutical companies that limit their ability to stop generic drugs from other companies? >> i've already well into the health debate as you know and i think, yes, there is a problem with that but some of it is patent laws and i want to add to that, it's not always the generics that are better than the brand name drug and president obama says the red pill or blue pill and sometimes the red pill and the blue pill and i don't want to take away doctors' choices and i want to move towards generic drugs and they are cheaper and are often just as good, and i don't want to take away the physicians' choice. >> julie: the. if d
. >> that is this point, the fda is this point person, and this fda is not involved now and now only pharmacies are involved and to get this fda involved, gregg, you use the data to benefit patients and if the drug is doing what people say it is or side effects people are not considering, once a drug is enforced -- approved there are not a lot of studies after that and it is a vast amount of data, as long as it is used properly. >> gregg: should there be a block on pharmaceutical...
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525
Aug 11, 2009
08/09
by
WJLA
tv
eye 525
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the fda requires all prescription nsaids, including celebrex, ibuprofen, naproxen and meloxicam, to have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart disease or risk factors for it such ashigh blood pressure or when nsaids are taken for long periods. all prescription nsaids, including celebrex, also increase the chane of serious skin reactions or stomach nd intestine problems,, such as bleeding and ulcers, which can occur without " warning and may cause death. patients also taking aspirin and the elderly are at increased risk for stomach bleeding and ulcers. do not take celebrex if you're allergic to aspirin or sulfonamides. ask your doctor if you could benefit from celebrex. understand the risks. eel the benefits. >>> finally tonight, to catch a thief. or try to. in this case, it's actually a couple of thieves. two well-dressed men showed up at one of the fanciest jewelry stores in london and got away with a fortune in gems. it sounds like something out of the movies. so, wha
the fda requires all prescription nsaids, including celebrex, ibuprofen, naproxen and meloxicam, to have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart disease or risk factors for it such ashigh blood pressure or when nsaids are taken for long periods. all prescription nsaids, including celebrex, also increase the chane of serious skin reactions or stomach nd intestine problems,, such...
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185
Aug 4, 2009
08/09
by
WMAR
tv
eye 185
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based on the available data, the fda stated that for certain patients celebrex's benefits outweigh the risks. if you are worried about stomach upset, you should know, in clinical studies, a lower percentage of patients taking celebrex reportedtomach discomfort versus prescription ibuprofen and naproxen. and if you are taking low-dose aspirin for your heart and need an nsaid pain reliever, celebrex can be used because it doesn't interfere with the effects of low-dose aspirin. but when it comes to relieving your arthritis pain, you and your doctor need to balance the benefits with the risks. the fda requires all prescription nsaids, including celebrex, ibuprofen, naproxen and meloxicam, to have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart disease or risk factors for it such as high blood pressure or when nsaids are taken for long periods. all prescription nsaids, including celebrex, also increase the chance of serious skin reactions or stomach and intestine problems, such as b
based on the available data, the fda stated that for certain patients celebrex's benefits outweigh the risks. if you are worried about stomach upset, you should know, in clinical studies, a lower percentage of patients taking celebrex reportedtomach discomfort versus prescription ibuprofen and naproxen. and if you are taking low-dose aspirin for your heart and need an nsaid pain reliever, celebrex can be used because it doesn't interfere with the effects of low-dose aspirin. but when it comes...
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Aug 26, 2009
08/09
by
WMAR
tv
eye 174
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what the fda is investigating now. >>> and drug and alcohol addictions sends people to rehab. what if you are addicted to technology? >>> and the latest on the chris brown/rihanna saga. what sentence the pop star received. coming up. >>> and while it's a little warmer and humid today, we should have a hot dry day but we're watching the tropics. a brand new tropical storm could reach us this weekend. >>> traffic looks good at route 50 and route 97 but we have several roads closed downtown. i'll get you up to date after we come back. my name is chef michael. and my dog bailey and i love to hang out in the kitchen... so she can watch me cook. you just love the aromas of beef tenderloin... and, ooh, rotisserie chicken. yes, you do. [ barks ] yeah. you're so special, you deserve a very special dog food. [ woman ] introducing chef michael's canine creations. the deliciously different way to serve up your love at mealtime. chef-inspired. dog-desired. chef michael's canine creations. >>> "2 your health." the food and drug administration is looking into claims that the popular weight l
what the fda is investigating now. >>> and drug and alcohol addictions sends people to rehab. what if you are addicted to technology? >>> and the latest on the chris brown/rihanna saga. what sentence the pop star received. coming up. >>> and while it's a little warmer and humid today, we should have a hot dry day but we're watching the tropics. a brand new tropical storm could reach us this weekend. >>> traffic looks good at route 50 and route 97 but we have...
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467
Aug 25, 2009
08/09
by
WBAL
tv
eye 467
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. >>> the fda is investigating 30 reports of liver damage in some people taking the weight loss drug alli or prescription zen cal. the fda has it has not established a link between the weight loss drugs and liver problems and advises patients to continue using them as directed by their doctors. >>> thunderstorms forced nasa to postpone this morning's launch of the space shuttle "discovery." nasa will try again early tomorrow. >>> you're up to date right now. five minutes past the hour. back outside again to matt and ann. >> thanks, natalie. >> mr. roker a right behind you. >> got a couple of young ladies who want to let some folks know back home something? >> hi. >> we're pretty good. >> both of you. >> yeah. >> your husbands are -- >> chris. >> how far apart? >> two weeks. >> man! you guys really believe in double dating. >>> let's check your weather, see what's going on. eye on the tropics, got a tropical wave interacting with an upper-level low east of san juan, could become a tropical cyclone in the next two days, that would become danny. closer to home, showers and thunderstorms
. >>> the fda is investigating 30 reports of liver damage in some people taking the weight loss drug alli or prescription zen cal. the fda has it has not established a link between the weight loss drugs and liver problems and advises patients to continue using them as directed by their doctors. >>> thunderstorms forced nasa to postpone this morning's launch of the space shuttle "discovery." nasa will try again early tomorrow. >>> you're up to date right now....
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no reports have been given to the fda. >>> two people were killed and 11 others were wounded saturday night when a masked man stormed a center for gay teens and opened fire. demonstrators worry that the attack could mean or what it could mean for the country's gay community. >> you know, i think any decent human being, whatever religion or belief, can't accept it. my kids, who are the authorities, will do enough to catch these people. >> they said the killer will be found and brought to justice. >>> a stage collapsed at a country music festival, and actor kevin cost ner was one of the dozen. >>> time for you to rise and shine. monday morning. how was your weekend? that good, huh? i'm robin meade. welcome. >>> you know, lawmakers are trying to take up billions of dollars to keep that cash for clunkers program alive that was so popular, but some new developments could stop you from cashing in on the deal. >> the night before i went to the white house, i dreamed i got arrested in the white house. >> harvard professor henry louis gai gates is joking about his arrest, but you have to hear
no reports have been given to the fda. >>> two people were killed and 11 others were wounded saturday night when a masked man stormed a center for gay teens and opened fire. demonstrators worry that the attack could mean or what it could mean for the country's gay community. >> you know, i think any decent human being, whatever religion or belief, can't accept it. my kids, who are the authorities, will do enough to catch these people. >> they said the killer will be found...
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108
Aug 12, 2009
08/09
by
CNBC
tv
eye 108
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key decisions loom from the fda. joining us, mike, what are we looking for? >> even though he went to notre dame and he loves the fighting irish whose butts sc's going to kick in a couple of months. but regis was here yesterday literally pounding this table for fooizer and mott in a good way. >> fiz when is pfiser stock going to move? >> it went up a whole three cents. not even the relatively influential pharma analyst at deutsche bank could move this needing today. she put out a note saying i think they're going to raise their dividend again by 15% to 25% in november. remember they cut the dividend in half when they announced they were buying wyeth earlier this year. >> i got to ask you. in this whole space, we talk about big pharma, talk about the big biotechs. it's always very exciting. how about generics? are they overvalued right now? that's the sector that is really taken off, all moving to the up side. are they too far in front of themselves? the growth is incredible. >> i don't make valuation calls but you guys all know tens of billions of dollars of
key decisions loom from the fda. joining us, mike, what are we looking for? >> even though he went to notre dame and he loves the fighting irish whose butts sc's going to kick in a couple of months. but regis was here yesterday literally pounding this table for fooizer and mott in a good way. >> fiz when is pfiser stock going to move? >> it went up a whole three cents. not even the relatively influential pharma analyst at deutsche bank could move this needing today. she put...
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209
Aug 26, 2009
08/09
by
WMAR
tv
eye 209
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so far both the fda and alli's maker glaxosmithkline say there is no link between the drug and liver damage. they now a disease once thought to be a death sentence. thanks to new cutting edge technology, a diagnosis of lung cancer doesn't mean what it used to. abc 2 news health reporter kelly swoope introduces us to a woman who knows that all too well. >> this is it. i'm going to die. i wouldn't see my child graduate from high school. and i needed to not ruin his senior year. >> reporter: that's what went through roxanne's mind when she was diagnosed with inoperable lung cancer two years ago. she says she never saw it coming. >> i had no hope of survival. i was just maintaining. that is gone. >> we know the last pet scan you had shows absolutely no cancer. everything is clear. >> reporter: this machine gets the credit. it's called the cyber knife. and roxanne says it saved her life. >> the cyber knife is a form of radiation therapy. >> reporter: dr. akub, a radiation oncologist says the cyber knife provides a targeted form of treatment. >> with this procedure we're able to target the
so far both the fda and alli's maker glaxosmithkline say there is no link between the drug and liver damage. they now a disease once thought to be a death sentence. thanks to new cutting edge technology, a diagnosis of lung cancer doesn't mean what it used to. abc 2 news health reporter kelly swoope introduces us to a woman who knows that all too well. >> this is it. i'm going to die. i wouldn't see my child graduate from high school. and i needed to not ruin his senior year. >>...
135
135
Aug 25, 2009
08/09
by
WMAR
tv
eye 135
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unlike some other cholesterol lowering medications, lipitor is fda approved to reduce the risk... of heart attack, stroke, and certain kinds of heart surgeries... in patients with several common risk factors... or heart disease. lipitor has been extensively studied... with over 16 years of research. lipitor is not for everyone, including people with liver problems... and women who are nursing, pregnant, or may become pregnant. you need simple blood tests to check for liver problems. tell your doctor if you are taking other medications, or if you have any muscle pain or weakness. this may be a sign of a rare but serious side effect. i was caught off-guard. but maybe you can learn from my story. have a heart to heart with your doctor... about your risk. and about lipitor. >>> you're watching baltimore's station that works for you. now abc 2 news at 5. >> we've all been there, the first day of school jitters, butterflies in your stomach and all. and that can be really tough on your kid. that's why a school in texas is using therapy dogs to help calm those back-to-school nerves. their
unlike some other cholesterol lowering medications, lipitor is fda approved to reduce the risk... of heart attack, stroke, and certain kinds of heart surgeries... in patients with several common risk factors... or heart disease. lipitor has been extensively studied... with over 16 years of research. lipitor is not for everyone, including people with liver problems... and women who are nursing, pregnant, or may become pregnant. you need simple blood tests to check for liver problems. tell your...