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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Black Box 'Best Case' Hopes On Vaginal Estradiol Dashed For TherapeuticsMD
Echoing complaints of other recent complete response recipients, TherapeuticsMD charges that US FDA's request for 12-month safety data for the dyspareunia therapy TX004HR is not consistent with earlier communications with agency.
Valbenazine FDA Panel Cancellation Is A Good Sign, Neurocrine Says
US agency's decision not to hold a February advisory committee review of tardive dyskinesia treatment viewed positively by Neurocrine, which emphasized quality of its communications with the review division and the drug's breakthrough therapy status.
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.