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                FDA Basics for Industry

FDA Basics for Industry

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          FDA Basics for Industry
          GuidancesFDA Basics for Industry Guidances
  
  	
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    PrintGuidance 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.

Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies.

Search for FDA Guidance Documents

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

**Search for official FDA guidance documents and other regulatory guidance**

How to Provide Input for Guidance Development

Interested parties have a number of opportunities to provide input into guidance development. For more information please see Opportunities for Input Into Guidance Development (PDF - 21 KB).

Interested parties also have a number of opportunities to comment on agency rulemaking. For more information please see Comment on Proposed Regulations and Submit Petitions.

Possible Topics for Future Guidance Development

Animal and Veterinary
	Center for Veterinary Medicine Guidance Documents Under Development
	Medical Devices and Radiation-Emitting Products  
	Center for Devices and Radiological Health Proposed Guidance Development
	Drugs
	Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2018 (PDF - 46KB)
	Vaccines, Blood & Biologics
	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022Guidance Documents By Product Area

All FDA Guidances
	Combination Products
	Animal and Veterinary
	Recent Animal and Veterinary Guidances
	Color Additives
	Cosmetics
	Drugs
	Recent Drugs Guidances
	Food
	Recent Food Guidances
	Medical Devices
	Radiation-Emitting Products
	Recent Radiation-Emitting Guidances
	Tobacco Products
	Vaccines, Blood, Biologics
	Recent Vaccines, Blood, Biologics GuidancesGuidance Documents By Topic

General and Cross-Cutting Topics
	Advisory Committee
	Clinical Trials
	Import and Export
	International Council for Harmonisation (ICH)
	Veterinary International Conference on Harmonization (VICH)Withdrawn Guidance Documents

Animal and Veterinary
	Withdrawn/Replaced Guidances
	Drugs
	Withdrawn Guidances
	Medical Devices
	Withdrawn Guidance

                                                                                  Content current as of:
      12/21/2023FDA Basics for Industry

          
                        Guidances
          Registration and Listing
          Regulatory Process
          Product Application and Petition Review Process
          Stay Informed With FDA Program Areas
          Search Databases
          Popular Content
          Industry Frequently Asked Questions
          Educational Resources
          Compliance and Enforcement
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
          Imports
          Submit Questions and Comments
 
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