7:00 AM GMT, Oct 5, 2009
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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
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