For Immediate Release: June 27, 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 published new frequently asked questions and additional tools to provide industry with …
For Immediate Release: June 27, 2023 Today, the U.S. Food and Drug Administration is providing an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). These additions …
For Immediate Release: June 23, 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 issued an updated Consumer Update to remind parents about the dangers of accidental …
For Immediate Release: June 22, 2023 Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in …
For Immediate Release: June 22, 2023 Today, the U.S. Food and Drug Administration is announcing it has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are …
For Immediate Release: June 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 released its report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and …
FDA News Release Pilot Geared Toward Sponsors of Certain Oncology Drug Products Used with Certain In Vitro Diagnostic Tests to Identify Patients for Certain Cancer Treatments For Immediate Release: June 20, 2023 Today, the U.S. Food and Drug Administration …
For Immediate Release: June 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 published the FDA Voices: “Accelerating Rare disease Cures (ARC) Program Emerges as a …
For Immediate Release: June 12, 2023 Today, the U.S. Food and Drug Administration issued a draft guidance to help manufacturers and distributors recognize situations that will prevent microbial contamination in tattoo inks. “With about 30 percent of people …
For Immediate Release: October 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 updated its infant formula compliance program for FDA investigators, laboratory …
For Immediate Release: June 09, 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 provided information to health care providers and facilities on oxygenator devices used in …
For Immediate Release: July 06, 2023 Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial …
For Immediate Release: June 06, 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 Letter to Health Care Providers recommending health care facilities and …
For Immediate Release: June 06, 2023 Español Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect …
For Immediate Release: May 30, 2023 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: May 30, 2023 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration Providing people with accurate and timely information to help them take their prescription medications safely and …
For Immediate Release: May 23, 2023 FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria Today, the U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment …
For Immediate Release: May 23, 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 and the Veterans Health Administration announced a new collaboration to jointly develop …
FDA News Release Nalmefene Hydrochloride Product in Nasal Spray Form Provides Additional Tool for Harm Reduction Groups and First Responders For Immediate Release: May 22, 2023 Today, the U.S. Food and Drug Administration approved Opvee, the first …
For Immediate Release: May 19, 2023 Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic …
