Healthy Skepticism Library item: 7282
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Publication type: news
UPDATE 1-US FDA to speed up review of certain generic drugs
Reuters 2006 Oct 18
http://today.reuters.com/news/articleinvesting.aspx?type=governmentFilingsNews&storyID=2006-10-18T141714Z_01_N18399467_RTRIDST_0_HEALTH-FDA-GENERICS-UPDATE-1.XML
Abstract:
Bids to sell some generic drugs now will be prioritized to receive faster, six-month reviews from U.S. regulators, a top Food and Drug Administration official said on Wednesday.
Applications may undergo the expedited review if they are the first for a generic version of a drug no longer protected by a patent or market exclusivity, or if the medicine would address a public health emergency or nationwide shortage, said Dr. Steven Galson, director for FDA’s Center for Drug Evaluation and Research.
The agency has a backlog of more than 800 generic drugs awaiting an approval decision under the current process that evaluates all applications in the order that it receives them. In 2005, the median time for an approval was more than 16 months, according to the FDA.
Under the new procedures, generic drug applications with priority status will expedited immediately, Galson said at a conference sponsored by the Generic Pharmaceutical Association.
“We should start seeing that right away, we think it’s realistic,” he said about the new six-month timeframe.
Top generic drugmakers include Teva Pharmaceutical Industries Ltd
