Guidance



Guidance definition is - the act or process of guiding. How to use guidance in a sentence. The act or process of guiding; the direction provided by a guide; advice on vocational or educational problems. Guidance Search The Department of Labor provides this guidance search tool as a single, searchable location where users may search for guidance issued by any of the Department’s agencies, including significant guidance documents under Executive Order 12866.

Guidance for Health Care, Configure, Child Care, Education, Businesses, Individuals, Families and Communities, Human Services, Housing and Sheltering, Veterinarians and Animal Services. Guidance for Adult Day Services Centers Strategies for administrators and staff to prevent the spread of COVID-19 in Adult Day Service Centers (ADSCs). ADSCs provide social or health services to community-dwelling adults aged 65 and over and adults of any age living with disability.

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.

Guidance

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.

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
  • Medical Devices and Radiation-Emitting Products
  • Drugs
  • Vaccines, Blood & Biologics
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Guidance Documents By Product Area

  • Animal and Veterinary
  • Drugs
  • Food
  • Medical Devices
  • Radiation-Emitting Products
  • Vaccines, Blood, Biologics

Guidance Documents By Topic

Withdrawn Guidance Documents

  • Animal and Veterinary
  • Drugs
  • Medical Devices

Guidance Counselor

About FDA Guidances

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, regulations, or both. For information on a specific guidance document, please contact the originating office. Another method of obtaining guidance documents is through the Division of Drug Information.

Guidance

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TOPICS Related to Drugs
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  • Product-Specific Guidances for Generic Drug Development (separate database)
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  • User Fees
Guidance

Good Guidance Practices

  • FDA's Good Guidance Practices regulation (PDF - 162KB) September 2000

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Newly Added Guidances

Guidance 5e

List of the most recently added guidances