Accelerated And Accompanied: Oncology Drugs Should Use Randomized Trials, FDA Panel Says
• By The Pink Sheet Daily
Single-arm studies for accelerated approval should be used only when the patient population is small or drug activity is high, the Oncology Drugs Advisory Committee says.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.