Search for FDA Guidance Documents

The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.

If you cannot find the document you’re looking for here, you can browse separate collections of guidance documents by topic.

Browse Guidance Documents By Topic

• General and Cross-Cutting Topics
• Advisory Committees
• Animal and Veterinary
• Biologics
• Clinical Trials
• Color Additives
• Combination Products
• Cosmetics
• Drugs
  • Product-Specific Guidances for Generic Drug Development (Bioequivalence Recommendations)

  About FDA Guidance Documents

  Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

  If you believe an FDA employee is not following FDA's Good Guidance Practice regulations (21 CFR 10.115), you should contact the employee's supervisor in the issuing office or Center. If the issue is not resolved, contact the next highest supervisor or the Center's Ombudsman. If the issue is still not resolved, contact the FDA's Office of the Ombudsman at:

  FDA Office of the Ombudsman
  10903 New Hampshire Avenue
  WO Bldg. 1, room 4208
  Silver Spring, MD 20993
  Phone : 301-796-8530
  Email: Ombuds@oc.fda.gov

  Some Web links (URLs) embedded within guidance documents may have changed since the document was published. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.

  Commenting on Guidance Documents

  Some FDA guidance documents on this list are indicated as open for comment. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on a draft guidance that is open for comments before it begins work on the final version of the guidance, submit either electronic or written comments by the closing date. Comments are submitted electronically through regulations.gov. For more information, see:

  • How to Use Regulations.gov
  • Find and Comment on FDA Dockets

  Report on Good Guidance Practices

  As part of the FDA's Transparency Initiative, Dr. Margaret A. Hamburg, the Commissioner of Food and Drugs, called for a cross-Agency working group to prepare a report identifying FDA's "best practices" for making the agency’s guidance development processes more transparent and efficient.

  The working group prepared a report, entitled "Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency."

  • Fact Sheet: FDA Good Guidance Practices
  • Report on Good Guidance Practices: Improving Efficiency and Transparency
  • Federal Register Notice of Availability