About FDA 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 statute and regulations.  Should you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to  Contact FDA. 

 

Guidance Topics in the Office of the Chief Scientist

• Advisory Committee Guidance Documents
• Cosmetics Guidance Documents
• Emergency Use Authorization of Medical Products and Related Authorities

Guidance Agenda Year 2024

• New and revised guidances OCS plans to publish

Good Guidance Practices

• FDA's Good Guidance Practices regulation (PDF - 162KB) September 2000
• How to comment on Guidance Documents

Contact FDA

For more assistance, explore ways to contact the FDA