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Generic drug citizen petitions would apply only "prospectively" under Barr proposal.

Executive Summary

GENERIC DRUG CITIZEN PETITIONS WOULD NOT AFFECT PENDING ANDAs UNDER BARR PROPOSAL outlined by Barr Labs CEO Bruce Downey at a May 21 meeting of the Food & Drug Law Institute in Washington, D.C. In order for a "change in existing standards to apply to a pending application," Downey said, FDA would have to meet "the same standard as for withdrawing products from the market." The Generic Pharmaceutical Industry Association said it supports Downey's proposal.
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