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Warning Letters Life Sciences Federal Food Drug and Cosmetic Act (FFDCA)

Sheppard Mullin Richter & Hampton LLP

FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations...more

Morgan Lewis

Electronic Drug Product Listing Errors Can Result in FDA Warning Letter

Morgan Lewis on

FDA Warning Letters focus on inaccurate drug product listings. Over the last year, the US Food and Drug Administration (FDA or Agency) has increased its enforcement efforts concerning drug product listing requirements,...more

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