Center For Drug Evaluation and Research List of Guidance Documents

Center For Drug Evaluation and Research List of Guidance Documents

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 statutes, regulations, or both. For information on a specific guidance document, please contact the originating office (see footnote 1 in recent guidances), or contact the Division of Drug Information in the Office of Training and Communications.

Office of Training and Communications
Division of Drug Information
10903 New Hampshire Avenue
Silver Spring, MD 20993
Telephone:
301-796-3400
Fax:
301-847-8714
Internet (I):
http://www.fda.gov/cder/guidance/index.htm
E-mail:
druginfo@fda.hhs.gov
Tuesday, December 1, 2009

abrir aquí:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079645.pdf