Drug Bill To Change ANDA Petition Process

Law360, New York (May 10, 2007, 12:00 AM EDT) -- A bipartisan amendment added to a bill renewing drug user fees that passed the U.S. Senate Wednesday would alter the citizen petition process for Abbreviated New Drug Applications, making it harder for brand-name drug makers to use "frivolous" petitions as a way to delay generic drugs, advocates say.

If made law, the amendment, which was sponsored by a bipartisan group of legislators including Sens. Debbie Stabenow (D-MI) and Trent Lott (R-Miss.), would mean that the U.S. Food and Drug Administration would no longer stop the approval...
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