For Immediate Release: August 02, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

On August 2, 2024, the Food and Drug Administration granted accelerated approval to afamitresgene autoleucel (TECELRA, Adaptimmune, LLC), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous […]

Español 药物安全通讯 Drug Safety Podcast 01-11-2024 FDA Drug Safety Communication Drug Safety Communication (PDF – 214 KB) The U.S. Food and Drug Administration (FDA) has been evaluating reports […]

Image By: Christine Lee, Acting Associate Commissioner for Minority Health, Office of Minority Health and Health Equity In late June, representatives of the U.S. Food and […]

FDA has reevaluated the rationale document titled, “Daptomycin Breakpoints for Enterococci,” submitted by the Clinical and Laboratory Standards Institute (CLSI) to FDA public docket # FDA-2017-N-5925-020 […]

Docket Number: FDA-2022-D-1527 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

Docket Number: FDA-2022-D-1527 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy Center for Biologics Evaluation and Research The Food […]

The Food and Drug Administration (FDA) recognizes that dealing with a large organization can frequently be a time consuming, frustrating experience. Although there is no acceptable […]

Docket Number: FDA-1998-D-0019 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance for industry provides the Agency’s current thinking on how to […]