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- Experts say MDUFA VI draft letter improves program while addressing FDA resource limitsIndustry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s…
- FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networksThe FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…