For Immediate Release: July 27, 2023 Today, the U.S. Food and Drug Administration announced new steps to help facilitate innovation in devices intended to treat opioid use disorder (OUD). The draft guidance, to help sponsors design clinical studies to …
For Immediate Release: July 25, 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 reopened the comment period for the 30-day procedural notice to conduct a study …
For Immediate Release: July 21, 2023 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration The U.S. Food and Drug Administration is working closely with Pfizer to assess the impact of the damage at …
For Immediate Release: July 21, 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 Center for Tobacco Products (CTP) announced that the center will host a virtual listening …
For Immediate Release: July 18, 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 announced the findings from the voluntary pilot program to evaluate alignment of …
For Immediate Release: July 17, 2023 Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering …
For Immediate Release: July 14, 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 re-issued two temporary guidances originally published during the COVID-19 public …
For Immediate Release: July 13, 2023 Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. …
For Immediate Release: July 11, 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’s Center for Veterinary Medicine (CVM) detailed how it is working to stop illicit xylazine …
For Immediate Release: November 07, 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 Safety Communication warning consumers, health care providers, and health …
For Immediate Release: August 07, 2023 Today, the U.S. Food and Drug Administration issued a draft guidance which, once finalized, will assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product listings, including …
For Immediate Release: July 07, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the U.S. Embassy & Consulates in India published a news release highlighting "Operation …
For Immediate Release: June 30, 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’s Center for Tobacco Products (CTP) Director Brian King published a statement …
For Immediate Release: June 29, 2023 Today, the U.S. Food and Drug Administration approved Roctavian, an adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A without pre-existing antibodies to adeno- …
For Immediate Release: June 28, 2023 Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is …
For Immediate Release: June 27, 2023 Hoy, la Administración de Alimentos y Medicamentos de Estados Unidos proporciona una actualización sobre su propuesta para crear un Programa de Alimentos Humanos (HFP, por sus siglas en inglés) unificado, que incluye un …
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 …
FDA News Release Agency Recommendations Aim to Inform Psychedelic Drug Development For Immediate Release: June 23, 2023 Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers …
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