Guidelines 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 Communications Management
Drug Information Branch
5600 Fishers Lane
Rockville, MD 20858

Telephone: 301-827-4573
Fax: 301-827-4577
Fax-on-Demand (FOD): 800-342-2722 or 301-827-0577
E-mail: druginfo@cder.fda.gov
Internet: http://www.fda.gov/cder/guidance.htm

List of Guidance Documents available.

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