Winston Kirton

Winston Kirton

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Latest Posts › Federal Food Drug and Cosmetic Act (FFDCA)

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FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more

5/2/2024  /  Clinical Laboratories , Compliance , Diagnostic Tests , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices

FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products

Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of...more

1/17/2024  /  Cosmetics , Federal Food Drug and Cosmetic Act (FFDCA) , Final Guidance , Food and Drug Administration (FDA) , Labeling , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , Personal Care Products , Registration Requirement
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