FDA seeks ways to improve accelerated approvals, as drug makers explain delays
This article was originally published in Scrip
In reviewing the reasons why five drug makers' have failed to fulfil postmarketing confirmatory study commitments on time for drugs for which they received accelerated approval, the US FDA is hoping its Oncologic Drugs Advisory Committee (ODAC) at a 8 February meeting can provide advice about how to improve the efficiency of the expedited program for cancer drugs.
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