For Immediate Release: April 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’s Center for Devices and Radiological Health (CDRH) announced the unveiling of a new …
For Immediate Release: April 12, 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at-a-glance summary of news from around the agency: Today, the FDA will reopen the comment period for 60 days for the draft guidance “Recommendations for …
For Immediate Release: October 04, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, Oct. 7, the Science Board to the FDA will convene to receive an update from the New …
For Immediate Release: April 09, 2024 Today, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America LLC (“Philips Respironics”), Respironics California LLC, and …
For Immediate Release: April 09, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA authorized for marketing MMI North America, Inc.’s Symani Surgical System, indicated …
For Immediate Release: June 04, 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 published When We Work Together, Hand in Glove with Our Partners, We Can Overcome Any …
For Immediate Release: April 05, 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 an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & …
For Immediate Release: March 29, 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 made several updates to the Mammography Quality Standards Act and Program section …
For Immediate Release: March 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 proposed a ban of electrical stimulation devices intended to reduce or stop self- …
FDA News Release Agency Issues Warning Letters to Six Companies for Marketing Unapproved, Misbranded Products For Immediate Release: March 26, 2024 The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic ( …
For Immediate Release: March 22, 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 an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure …
For Immediate Release: March 21, 2024 Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first …
For Immediate Release: March 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 provided an update on our evaluation of quality and performance issues related to plastic …
For Immediate Release: March 18, 2024 Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic …
For Immediate Release: March 15, 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 published its new paper, “Artificial Intelligence and Medical Products: How CBER, CDER, …
For Immediate Release: March 14, 2024 Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be …
For Immediate Release: March 12, 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 the draft guidance Select Updates for the Premarket Cybersecurity Guidance: …
For Immediate Release: December 03, 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 the final guidance on Marketing Submission Recommendations for a Predetermined …
For Immediate Release: December 03, 2024 The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) today are announcing a joint Request for Information (RFI) about food date labeling, which includes the use of terms such as …
For Immediate Release: March 11, 2024 Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and …
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