FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 31, 2023 - 16:25 GMT

FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities

For Immediate Release: January 31, 2023 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration As the oldest comprehensive consumer protection agency in the country, for more than a century the U.S. Food …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 30, 2023 - 21:22 GMT

Federal Court Enters Consent Decree Against Florida-based Drug Importer and Distributor

For Immediate Release: January 30, 2023 Today, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against LGM Pharma LLC, an importer and distributor of active pharmaceutical ingredients (API), …

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Published on January 27, 2023 - 14:02 GMT

FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard U.S. Blood Supply

For Immediate Release: January 27, 2023 The U.S. Food and Drug Administration today announced it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk …

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Published on January 26, 2023 - 15:20 GMT

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with ...

For Immediate Release: January 26, 2023 Statement From: Janet Woodcock, M.D. Principal Deputy Commissioner - Office of the Commissioner Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level …

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Published on January 24, 2023 - 18:47 GMT

FDA Roundup: January 24, 2023

For Immediate Release: January 24, 2023 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 a final guidance “Cannabis and Cannabis-Derived Compounds: Quality …

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Published on January 24, 2023 - 15:34 GMT

FDA Denies Marketing of Two Vuse Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

FDA News Release Company Must Stop Marketing Unauthorized Products or Risk Enforcement For Immediate Release: January 24, 2023 Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently …

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Published on January 24, 2023 - 15:34 GMT

FDA Announces Action Levels for Lead in Categories of Processed Baby Foods

For Immediate Release: January 24, 2023 Today, the U.S. Food and Drug Administration is announcing draft guidance for industry on action levels for lead in processed foods that are intended for babies and children under two years of age, to help reduce …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 20, 2023 - 22:36 GMT

FDA Roundup: January 20, 2023

For Immediate Release: January 20, 2023 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 an immediately-in-effect guidance on compounding certain ibuprofen products in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 13, 2023 - 21:03 GMT

FDA Roundup: January 13, 2023

For Immediate Release: January 13, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA released a fact sheet and constituent update to remind produce stakeholders of the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 12, 2023 - 16:46 GMT

FDA Roundup: December 1, 2023

For Immediate Release: December 01, 2023 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 rolled out new tools and FAQs to continue to inform stakeholders about the Food …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 10, 2023 - 22:12 GMT

FDA Roundup: January 10, 2023

For Immediate Release: January 10, 2023 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 the final guidance for the Foreign Supplier Verification Programs for Importers …

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Published on January 9, 2023 - 14:01 GMT

FDA Roundup: September 1, 2023

For Immediate Release: September 01, 2023 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 cleared for marketing the updated 23andMe Personal Genome Service (PGS) Genetic …

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Published on January 9, 2023 - 10:25 GMT

La FDA emite cartas de advertencia a tres fabricantes de fórmula infantil

For Immediate Release: August 30, 2023 English Hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) emitió cartas de advertencia a tres fabricantes de fórmula infantil como parte del compromiso continuo …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 8, 2023 - 17:19 GMT

FDA Roundup: August 1, 2023

For Immediate Release: August 01, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA and the Drug Enforcement Administration provided an update on the ongoing actions being …

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Published on January 6, 2023 - 20:41 GMT

FDA Roundup: January 06, 2023

For Immediate Release: January 06, 2023 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 an update that the agency is closely monitoring the emergence of the XBB.1.5 …

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Published on January 6, 2023 - 19:14 GMT

FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment

For Immediate Release: January 06, 2023 Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of medications …

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Published on January 5, 2023 - 13:57 GMT

FDA Conditionally Approves First Drug for Anemia in Cats with Chronic Kidney Disease

FDA News Release First Approval for Cats Under Conditional Approval Pathway For Immediate Release: May 01, 2023 Today, the U.S. Food and Drug Administration conditionally approved Varenzin-CA1 (molidustat oral suspension), the first drug for the control of …

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Published on January 2, 2023 - 18:01 GMT

FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis

For Immediate Release: February 01, 2023 Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have …

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Published on December 30, 2022 - 16:52 GMT

FDA Roundup: December 30, 2022

For Immediate Release: December 30, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced, through a Constituent Update and corresponding rule in the Federal Register, …

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Published on December 23, 2022 - 17:07 GMT

FDA Roundup: December 23, 2022

For Immediate Release: December 23, 2022 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 announced that the VQIP Application Portal would open on January 1, 2023 for …

Distribution channels: Healthcare & Pharmaceuticals Industry