PREMIUM NEWS ARCHIVE
Article from: Adverse Event Reporting News
Article date: November 5, 2007
Through Oct. 31, FDA had approved just 15 drugs classified as "new molecular entities," a pace at which the agency would green-light just 18 new drugs (not counting vaccines or additional uses for existing drugs) by year-end, Dow Jones Newswires reported.
By comparison, FDA approved 22 NMEs last year, 20 in 2005 and 36 in 2004.
Some companies pin the blame on a skittish FDA. Safety worries since Merck withdrew painkiller Vioxx three years ago have put a chill on the agency, they say. FDA concerns have delayed several ...
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