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On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration...
On December 18, 2023, the FDA launched Cosmetics Direct, an electronic submission portal for product listing and facility registration required under the Modernization of Cosmetics Regulation Act (MoCRA).
FDA issues guidance and recommendations for New Drug Applications (NDA) and Biologic Laboratory Applications (BLA) which implicate oncology therapies and warrant Real-time Oncology Review (RTOR).
/PRNewswire/ -- I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up, announced that its cell manufacturing facility is now listed on the FDA...
On January 10, 2022, the US Food and Drug Administration (FDA or Agency) published a new draft guidance (Draft Guidance) on manufacturer's requirements to report certain medical device shortages.