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 […]

Our regulatory science programs are intended to provide FDA reviewers, and the wider drug development community, with the knowledge and the tools they need to evaluate […]

Español Drug Safety Podcast 6-1-2022 FDA Drug Safety Communication Drug Safety Communication (PDF – 197 KB) Due to safety concerns, the U.S. Food and Drug Administration […]

Since 2015 when FDA first alerted the public about cases of underactive thyroid in infants receiving iodinated contrast media (ICM), several research studies evaluating this risk […]

A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature1,2 through December 31, 2018, identified 305 cases of dental adverse events […]

On This Page Date: September 6, 2024 Time: 9:00 AM – 5:00 PM ET Workshop Location FDA White Oak CampusBuilding 31, Conference Center, The Great Room10903 […]