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  1. Guidance, Compliance, & Regulatory Information

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