FDA encourages interested parties who are considering the use of Digital Health Technologies (DHTs) in drug development or conducting decentralized clinical trials (DCTs) to engage the […]

Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information […]

Mission The mission of the Controlled Substance Staff (CSS) is to promote the public health through the medical science-based assessment and management of drug abuse risks. […]

Controlled Substance Staff Functional Roles | FDA In this section: CDER Offices and Divisions Home About FDA FDA Organization Center for Drug Evaluation and Research (CDER) […]

Docket Number: FDA-2018-D-0342 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations for the […]

For Immediate Release: August 07, 2024 Today, the U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known […]

What are the possible side effects (results of trials used to assess safety)? Table 6 summarizes the adverse reactions in the 339 patients who received TALVEY […]

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

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