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 […]

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 […]

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 […]