OII Guidance Documents

Related Resources
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Good Guidance Practices

• FDA's Good Guidance Practices (GGP) Regulation 
• How to comment on Guidance Documents
• Instructions for Submitting Drafts of Proposed Guidance Documents Electronically

Policy Resources

• Manual of Compliance Policy Guides

Other Procedural Resources

• Investigations Operations Manual
• Regulatory Procedures Manual
• Laboratory Manual
• Import Alerts

Contact FDA

• For more assistance, explore ways to contact the FDA

About OII Guidances at FDA

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 and regulations.

Other Center Guidance Pages

• Center for Biologics Evaluation and Research (CBER)
• Center for Drug Evaluation and Research (CDER)
• Center for Devices and Radiological Health (CDRH)
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Tobacco Products (CTP)
• Center for Veterinary Medicine (CVM) 

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