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- Consumer groups call on FDA to strengthen generic drug testing and safety reporting under GDUFA IVConsumer health organizations used a public meeting on the reauthorization of the Generic Drug User Fee Amendments to press the FDA for more resources dedicated to testing generic medicines. The g…
- Regulators Share Guidance for Effective Sponsor MeetingsRegulators from the U.S. FDA, the U.K. MHRA and other European agencies met to outline best practices for sponsor‑regulator interactions. They highlighted that transparency, open collaboration, at…