Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload
Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.
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Some ACIP members argued woman older than 50 should also be singled out in warning for Johnson & Johnson’s COIVD-19 vaccine and said that people need to be more clearly told they can get alternative vaccines that don’t have this risk.
Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.
Increasing number of product development meetings suggests that many complex generics remain in the development stages.