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- FDA issues warning letters to Baxter and Olympus over GMP and QSR violationsThe U.S. Food and Drug Administration sent formal warning letters to Baxter International and Olympus Medical Systems. The letters allege that both companies failed to meet required good manufactu…
- EMA opens consultation on platform trial methodology; MHRA to recognize CE-marked devices indefinitelyThe European Medicines Agency is launching a public consultation to gather feedback on the methodological aspects of confirmatory platform clinical trials. The agency seeks input from researchers,…