An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Guidances | Drugs

Guidance Documents: Division of Drug Information

Guidance Documents that are Applicable to the Center for Drug Evaluation and Research's Regulations

Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.

Office of Training and Communications
Division of Drug Information
WO51, Room 2201
10903 New Hampshire Ave
Silver Spring, MD 20993

Phone: 301-796-3400
Fax: 301-847-8714
E-mail: druginfo@fda.hhs.gov

Top