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 […]

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The FDA published Good Guidance Practices in February 1997.  This guidance was developed and issued […]

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]