FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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For Immediate Release: January 24, 2023 Today, the U.S. Food and Drug Administration is announcing draft guidance for industry on action levels for lead in processed foods that are intended for babies and children under two years of age, to help reduce …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

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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

Published on December 22, 2022 - 15:51 GMT

FDA Approves New HIV Drug for Adults with Limited Treatment Options

For Immediate Release: December 22, 2022 Today, the U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections …

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Published on December 20, 2022 - 20:55 GMT

FDA Roundup: December 20, 2022

For Immediate Release: December 20, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the agency published a piece for FDA Voices: “Office of Digital Transformation’s New Focus on …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 19, 2022 - 22:25 GMT

Federal Court Enters Consent Decree Against Oklahoma Drug Compounder

FDA News Release Company prohibited from distributing drug products that violate the law For Immediate Release: December 19, 2022 Today, the U.S. District Court for the Western District of Oklahoma entered a consent decree against Qualgen LLC, an …

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