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- Tarver: CDRH on a ‘recruiting tear,’ looking ahead to MDUFA VIBOSTON – Top US Food and Drug Administration (FDA) medical device officials said they are focused on restaffing after last year’s reduction-in-force (RIF) and are optimistic about the Medical Devic…raps · 23h ago↗ source
- Drugmakers urge FDA take more flexible approach to container closure testingMajor pharmaceutical companies are urging the US Food and Drug Administration (FDA) to adopt a more flexible, risk-based approach in its guidance on testing container-closure systems (CCS) for drug…raps · 23h ago↗ source
- FDA approves Hibsago, first antisense therapy for chronic hepatitis BThe U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…