Docket Number: FDA-2022-D-0738 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Pediatric Therapeutics Center for Biologics Evaluation […]

Updated April 11, 2024 Note:This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the […]

For Immediate Release: May 23, 2019 Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies […]

Who is affected by high blood pressure? Nearly half, more than 119 million, American adults have high blood pressure. But only about 1 in 4 of […]

To promote shared learning and understanding with external stakeholders, FDA continues to oversee and support numerous demonstration (i.e., research) projects on Digital Health Technologies (DHTs) through […]

With the start of GDUFA III in FY 2023, the Generic Drugs Program monthly and quarterly activities reports were combined into one report. Also, reported metrics […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

On this page As displayed in the Federal Register notice on October 20, 2022, FDA is continuing the Complex Innovative Trial Design (CID) Paired Meeting Program, […]

Docket Number: FDA-2001-D-0137 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations for sponsors of orally inhaled and intranasal corticosteroids […]