FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on August 16, 2024 - 14:51 GMT

FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis

For Immediate Release: August 16, 2024 Today, the U.S. Food and Drug Administration granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema pallidum ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 15, 2024 - 18:52 GMT

FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S.

For Immediate Release: August 15, 2024 Statement From: Jim Jones Deputy Commissioner for Human Foods - Food and Drug Administration Last fall, the U.S. Food and Drug Administration and our regulatory health partners at the North Carolina Department of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 15, 2024 - 13:24 GMT

FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain Foods

For Immediate Release: August 15, 2024 Image Today, the U.S. Food and Drug Administration marked a milestone building on Phase I of its voluntary sodium reduction targets and issued draft guidance for Phase II in a data-driven, stepwise approach to help …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 13, 2024 - 21:39 GMT

FDA Roundup: August 13, 2024

For Immediate Release: August 13, 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 two warning letters issued to BullyKamp Products LLC and Top Dog Pet Store LLC …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 11, 2024 - 15:05 GMT

FDA Roundup: November 8, 2024

For Immediate Release: November 08, 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 final rule, to amend the color additive regulations to increase the fees for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 10, 2024 - 16:40 GMT

Federal Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following Multistate Outbreak of Listeriosis Linked to Queso ...

For Immediate Release: October 08, 2024 Today, the U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction against Rizo Lopez Foods Inc. (“Rizo Lopez Foods”), a California-based food manufacturer, and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 10, 2024 - 00:33 GMT

Maine smoked fish company agrees to halt production of adulterated fish

For Immediate Release: February 16, 2016 On Friday, Feb. 12, U.S. District Judge Jon D. Levy of the District of Maine entered a consent decree of permanent injunction against Mill Stream Corporation, doing business as Sullivan Harbor Farm, and its former …

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Published on August 9, 2024 - 19:55 GMT

FDA Roundup: August 9, 2024

For Immediate Release: August 09, 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 invites the public to register for the public meeting on the Development of an Enhanced …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2024 - 15:30 GMT

FDA Approves First Nasal Spray for Treatment of Anaphylaxis

For Immediate Release: August 09, 2024 Today, the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 30, 2024 - 19:49 GMT

FDA Roundup: July 30, 2024

For Immediate Release: July 30, 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 is announcing the fiscal year (FY) 2025 user fee rates for importers approved to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 26, 2024 - 20:34 GMT

FDA Roundup: July 26, 2024

For Immediate Release: July 26, 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 approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to include initiation …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 23, 2024 - 20:05 GMT

FDA Roundup: July 23, 2024

For Immediate Release: July 23, 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 approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 16, 2024 - 21:40 GMT

FDA Roundup: July 16, 2024

For Immediate Release: July 16, 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 announced the revised final guidance Application User Fees for Combination Products. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 16, 2024 - 17:37 GMT

FDA, FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products

FDA News Release FDA, FTC Issue Warning Letters to Companies Selling Food Products Containing Delta-8 THC That Mimic Chips, Candies and Snacks from Popular National Brands For Immediate Release: July 16, 2024 Today, the U.S. Food and Drug Administration …

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Published on July 12, 2024 - 18:52 GMT

FDA Roundup: July 12, 2024

For Immediate Release: July 12, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA issued a Letter to Health Care Providers to notify providers that we are aware the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 11, 2024 - 09:26 GMT

FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review

For Immediate Release: November 07, 2024 Today, the U.S. Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 10, 2024 - 17:52 GMT

FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities

For Immediate Release: October 07, 2024 Today, the U.S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2024 - 20:29 GMT

FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose

FDA News Release Agency Continues to Support Development of Overdose Reversal Drugs including Naloxone and Nalmefene For Immediate Release: August 07, 2024 Today, the U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2024 - 15:20 GMT

FDA Updates Guidance to Further Empower Companies to Address the Spread of Misinformation

For Immediate Release: July 08, 2024 Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 27, 2024 - 19:02 GMT

FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test

For Immediate Release: June 27, 2024 Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to …

Distribution channels: Healthcare & Pharmaceuticals Industry