Guidances | Drugs
About FDA Guidances
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. Another method of obtaining guidance documents is through the Division of Drug Information.
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Good Guidance Practices
- FDA's Good Guidance Practices regulation (PDF - 162KB) September 2000
- How to comment on Guidance Documents
- Instructions for Submitting Drafts of Proposed Guidance Documents Electronically
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