First Generic Approvals Decline For Fourth Straight Year At US FDA
Blemish in otherwise record-setting performance could simply be a result of coalescing variables, but it robs the agency of an easy pricing message.
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Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.
Agency has acted on 84% of generic applications pending when user fee program launched, but most actions were 'complete response' letters, which do not reduce review workload.
More time is needed to gauge whether the US Food and Drug Administration's rare pediatric disease priority review voucher program has actually encouraged the development of new treatments, the Government Accountability Office believes. The FDA, however, isn't interested in giving the incentive program any more time to try to prove itself.