Pink Sheet Podcast: Roctavian CRL, COVID-19 Vaccine Adcomm Expertise, Pandemic Inspection Policies
Pink Sheet reporters and editors discuss the surprise US complete response letter for a new gene therapy and the specialists who may be added to the FDA’s coronavirus vaccine advisory committee, and also look at facility inspections during the pandemic.
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Pink Sheet reporters and editors discuss the performance of the leaders of several coronavirus vaccine manufacturers during a recent congressional hearing and consider proposed changes to the generic and prescription drug user fee programs.