Industry Notices and Guidance Documents

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.

Search for all FDA official guidance documents and other regulatory guidance

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

Search for FDA guidance documents

Browse Guidance Documents by Topic

• General and Cross-Cutting Topics
• Advisory Committees
• Animal and Veterinary
• Biologics, Blood and Vaccines
• Clinical Trials and Human Subject Protection
• Color Additives
• Combination Products
• Cosmetics
• Drugs
• Food
• Import and Export
• International Conference on Harmonisation (ICH)
• Medical Devices
• Radiation-Emitting Products
• Tobacco Products
• Veterinary International Conference on Harmonization (VICH)

For More Information

• More on guidance documents: FDA Basics for Industry

Industry Notices

Notices to industry on technical and regulatory topics

• General Biologics, Notices, Proposed and Final Rules
• Tissue Notices, Proposed and Final Rules
• Blood Notices, Proposed and Final Rules
• Vaccine Notices, Proposed and Final Rules
• Alerts and Notices (Radiation-Emitting Products)
• Notices to the Laser Industry
• eCTD Important Notices
• GCP/Clinical Trial Notices
• Warning Letters
• Notification to Industry: Products using oils, glycerin, or protein derived from the Jatropha plant may have toxic effects (Updated from July 2012)
• FDA Notification to Industry: Products using oils, glycerin, or protein that were derived from the Jatropha plant may have toxic effects