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The FDA is planning to expand its black box warning for all antidepressants to warn that young adults using these drugs face a greater risk of suicidality, the agency announced late Wednesday.
The FDA is supporting a user fee program for direct-to-consumer (DTC) advertising, where companies are only required to pay when they have ads up for review, a high-ranking agency official said.
Patients implanted with drug-eluting stents who have not had cardiovascular events or additional procedures within six months of follow-up may benefit from extended use of sanofi-aventis' blood-thinning drug Plavix, according to a study being published in the Jan. 10 issue of The Journal of the American Medical Association (JAMA).
The FDA is continuing its initiative to limit unapproved drugs by threatening enforcement actions against manufacturers of unapproved quinine products.
Both chambers of Congress passed legislation providing funding for biodefense programs and reauthorizing the NIH after a last-minute deal between Senate negotiators and Rep. Joe Barton (R-Texas), an industry source says.
An article published in the New England Journal of Medicine found that most patients participating in cancer clinical trials do not worry about financial conflicts of interest among researchers.
Generics could see wider use in Medicare Part D next year, as many of the new drug plans participating in the program substitute generics for their brand equivalents, according to a new side-by-side examination of the 2006 and 2007 programs by the Kaiser Family Foundation.
Trey Sunderland, a senior scientist at the National Institute of Mental Health (NIMH), pleaded guilty to participating in a conflict of interest by accepting $285,000 in consulting fees from Pfizer.