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United States - Food and Drugs Law - 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. ....

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FDA, CBER Publishes Warning Letter for Unresolved Inspection Obse

Center for Biologics Evaluation and Research and Food and Drug Administration FDA publish warning letter to Akan Biosciences for unresolved inspection observation ....

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(Maybe) I Can See More Clearly Now: FDA Issues Q&A Guidance on DTC Rx Ads | Arnall Golden Gregory LLP

On December 26, 2023, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a Questions and Answers Guidance for industry titled “Direct-to-Consumer. ....

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2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies | Morrison & Foerster LLP

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped. ....

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2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024… ....

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