Word: fda
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Dates: during 2000-2009
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...Exchange. Most riskily, he steered Rebif through a contentious approval process in the U.S. that involved taking on an already authorized rival treatment by Biogen in a head-to-head clinical trial--and winning. Biogen had enjoyed a temporary monopoly in the U.S. for its Avonex product under the FDA's "orphan drug" program, meant to encourage research into treatments for uncommon diseases. Serono broke the monopoly, proving by trial that its drug was more effective. Bertarelli's priority today is to fill Serono's pipeline with new drugs so it isn't so dependent on a few products...
...everyone takes it right, and even a single dose may not be safe for everyone. The FDA has received at least 1,500 reports of health problems associated with ephedra supplements, including almost 90 that resulted in death. The problem, says Dr. Harrison Pope, a Harvard psychiatrist who has studied supplements, is that it is hard to know exactly how many people use ephedra, which would tell doctors whether 1,500 is a significant portion. The ephedra industry says it is being unfairly targeted. "More than 16,000 deaths each year occur from the use of aspirin and similar drugs...
Unfortunately, delays and restrictions are becoming more common as a result of increasingly restrictive legislation. Bush’s new appointee to the FDA Reproductive Health Drugs Advisory Committee, David Hager, is in favor of making the morning-after pill, RU-486, illegal. Bush supports a policy that would prohibit military women serving abroad from obtaining safe medical abortions at local military hospitals overseas. Eighteen states have passed laws that force women to delay their abortions for a specified period of time, generally at least 24 hours. In some states, the laws require women to make two trips...
...FDA approves the first genetically engineered vaccine for humans for hepatitis...
...FDA allows the first genetically modified food product to market, the Flavr Savr tomato. A bland taste and high price make it a commercial...