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- Diamantas backtracks on Makary’s policies issued in journal articlesThe acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official ag…raps · 15d ago↗ source
- Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VIIndustry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…raps · 16d ago↗ source
- FDA Proposes Rule to Modernize Drug Manufacturing RegistrationThe U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a…