For Immediate Release: September 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 published the FDA Voices: “Join FDA for the First National Hispanic/Latino …
For Immediate Release: September 12, 2024 Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro …
FDA News Release Firms Provided Third-Party, Nonclinical Premarket Testing; Agency Review Ongoing For Immediate Release: September 11, 2024 Today, the U.S. Food and Drug Administration issued warning letters to two Chinese nonclinical testing laboratories, …
For Immediate Release: September 10, 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 a warning letter issued to Root Bioscience Brands LLC, doing business as …
For Immediate Release: August 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Related Information ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human …
For Immediate Release: August 30, 2024 Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better …
FDA News Release Tobacco Retailers Will Need to Verify Age for Anyone Under 30; Vending Machine Sales Will Be Restricted to 21+ Facilities For Immediate Release: August 29, 2024 Today, the U.S. Food and Drug Administration announced a final rule that …
For Immediate Release: August 27, 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 revised the Emergency Use Authorization for Pemgarda (pemivibart) to limit its use to …
FDA News Release Agency Supports Broader Access to Innovative Technology in Diabetes Management For Immediate Release: August 26, 2024 Today, the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an …
For Immediate Release: August 23, 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 Small Entity Compliance Guide (SECG) to assist small entities, including …
For Immediate Release: August 22, 2024 Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to …
For Immediate Release: August 20, 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 Lazcluze (lazertinib) in combination with amivantamab for the first-line …
For Immediate Release: August 16, 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 issued notice of a Warning Letter sent to AUSTROFOOD S.A.S. (Austrofood), the …
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 ( …
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 …
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 …
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 …
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 …
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 …
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 …
