US FDA Review Management Challenged After Spate Of Complete Response Letters
The past year has seen a sharp increase in the number of complete response letters issued to novel agent applications, and some sponsors are growing more publicly critical of the agency's timing of requests for more information; Dynavax’s complaint regarding the handling of Heplisav-B is the latest example.
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Keeping Track: FDA Approves First Rx DHEA, Receives Applications For Midostaurin, Gesulkumab, Biosimilar Avastin
The latest drug development news and highlights from our FDA Performance Tracker.