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12:00 AM
Oct 05, 2009
 |  BioCentury  |  Regulation

CDER Expands New Review Scheme

FDA's Center for Drug Evaluation and Research is expanding the use of new review procedures that it has been phasing in over the last two years. As of Oct. 1, the start of the federal government's fiscal year, NDAs for all new molecular entities (NMEs), as well as all original BLAs and efficacy supplements for new or expanded indications, will be processed using the 21st Century Review procedure.

The new procedures incorporate planning of post-market safety requirements early in the process - in some cases before an application is submitted - and hold both FDA reviewers and sponsors to tight deadlines.

However, even if there will be more transparency for sponsors, the procedures will do little if anything to prevent FDA from missing PDUFA goals. Indeed, the time frames are so tight, especially for priority applications, that virtually everything has to proceed perfectly for the agency to meet its PDUFA goals (see 21st Century Timetable").

Largely because of the time...

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