FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 6, 2025 - 17:04 GMT

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2025 - 15:54 GMT

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2025 - 15:27 GMT

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

FDA News Release Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 6, 2025 - 14:17 GMT

FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care that are used to estimate the …

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Published on January 4, 2025 - 12:45 GMT

Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner

For Immediate Release: April 01, 2025 Renowned surgeon-scientist and health policy expert, Martin A. Makary, M.D., M.P.H., took the oath of office to become the 27th Commissioner of Food and Drugs. Dr. Makary was confirmed by a bipartisan vote of the U.S. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 3, 2025 - 19:29 GMT

FDA Roundup: January 3, 2025

For Immediate Release: January 03, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a notice in the Federal Register with its determination that 35 food contact …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 27, 2024 - 20:35 GMT

FDA Roundup: December 27, 2024

For Immediate Release: December 27, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA announced recommended changes to labeling for transmucosal buprenorphine products …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 26, 2024 - 17:23 GMT

FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic ...

For Immediate Release: December 26, 2024 Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 23, 2024 - 16:38 GMT

FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes

For Immediate Release: December 23, 2024 Today, the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 20, 2024 - 22:32 GMT

FDA Approves First Medication for Obstructive Sleep Apnea

For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 20, 2024 - 20:27 GMT

FDA Roundup: December 20, 2024

For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided answers to a set of FAQs about software functions that may be described as …

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Published on December 20, 2024 - 14:32 GMT

FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities

For Immediate Release: December 20, 2024 The U.S. Food and Drug Administration approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization ( …

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Published on December 19, 2024 - 17:13 GMT

FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers

For Immediate Release: December 19, 2024 Today, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of preventable, diet-related chronic diseases …

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Published on December 18, 2024 - 21:48 GMT

FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease

For Immediate Release: December 18, 2024 Today, the U.S. Food and Drug Administration approved Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 17, 2024 - 21:52 GMT

FDA Roundup: December 17, 2024

For Immediate Release: December 17, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted four warning letters to companies for introducing unapproved GLP-1s, including …

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Published on December 13, 2024 - 23:09 GMT

FDA Approves New Treatment for Congenital Adrenal Hyperplasia

For Immediate Release: December 13, 2024 Today, the U.S. Food and Drug Administration approved Crenessity (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric …

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Published on December 13, 2024 - 19:40 GMT

FDA Roundup: December 13, 2024

For Immediate Release: December 13, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center …

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Published on November 26, 2024 - 20:13 GMT

FDA Roundup: November 26, 2024

For Immediate Release: November 26, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued this guidance: Transitional Enforcement Policy for Ethylene Oxide …

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Published on November 22, 2024 - 19:57 GMT

FDA Roundup: November 22, 2024

For Immediate Release: November 22, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA published the FDA Voices: “Upholding Public Trust: FDA Office of Criminal …

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Published on November 19, 2024 - 20:52 GMT

FDA Roundup: November 19, 2024

For Immediate Release: November 19, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a request for information (RFI) on per- and polyfluoroalkyl substances (PFAS) …

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