US FDA seeks ways to improve accelerated approvals, as drug makers explain delays
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration is holding a meeting on 8 February to review the reasons why five drug makers have failed to fulfil post-marketing confirmatory study commitments on time for drugs for which they received accelerated approval and to see whether it can provide advice about how to improve the efficiency of the expedited programme for cancer drugs1.
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