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- FDA acting commissioner says Makary’s journal policies are not official guidance; UK regulator reports rise in drug approvals and AI stepsThe acting commissioner of the U.S. Food and Drug Administration clarified that the policies published in medical journals by former commissioner Marty Makary do not constitute official FDA policy…
- 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…