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  5. Background: FDA Good Guidance Practices
  1. Guidances

Background: FDA Good Guidance Practices

FDA guidance documents explain the agency’s interpretation of, or policy on, a regulatory issue. The FDA prepares guidance documents for regulated industry, its own staff, and the public. FDA uses guidance documents to explain the Agency’s current thinking on such matters as the design, manufacturing, and testing of regulated products; scientific issues; content and evaluation of applications for product approvals; and inspection and enforcement policies.

Although guidance documents are not legally binding, they provide insight to approaches that may help regulated industry reach their regulatory goals. Other approaches that satisfy the relevant law and regulations may be used. FDA periodically reassesses its guidance practices and makes improvements, as appropriate, to ensure that FDA is using current best practices with regard to the prioritization, development, issuance, and use of its guidance documents.

Guidance Development

Level 1 guidance documents set forth the agency’s initial interpretations of statutory or regulatory requirements; describe changes in FDA’s earlier interpretation or policy that are of more than a minor nature; and deal with complex scientific or highly controversial issues.

In addition, FDA issues Level 2 guidance documents, which address existing practices or minor changes in FDA’s interpretation or policy.

Industry, consumers, and others play a significant role in the agency’s guidance development processes.  FDA welcomes suggestions of topics for guidance documents and proposed draft guidance documents may be submitted to FDA. Submitting proposed draft guidance documents, rather than guidance topics, may enable FDA to approach a guidance topic with a better understanding of the issues of interest.   

The agency also invites the public to comment on its draft Level 1 guidance documents and reviews and considers the submitted comments in preparing the final documents. In some instances, FDA may hold public meetings or workshops on published draft Level 1 guidance documents to solicit additional feedback, or present them to an advisory committee for review. 

Although Level 2 guidance documents and Level 1 guidance documents “for immediate implementation” are implemented without prior public comment, all FDA guidance documents are posted on the agency’s Website, and anyone can submit comments on any FDA guidance documents anytime. FDA reviews all comments and revises its guidance documents, as appropriate.

Guidance Best Practices

In 2011, FDA issued a report entitled "Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency." Developed by a cross-Agency working group, the report identified best practices and recommendations to streamline the development of guidance documents, reduce the time between issuing draft and final guidance documents, and make it easier to find guidance documents on FDA’s website.

Since 2011, FDA has made significant strides to modernize and enhance our best practices for the efficient initiation, prioritization, development, review, clearance, and issuance of guidance documents. In 2023, FDA prepared a draft document entitled “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance.” This draft report responded to section 2505(a) of the Consolidated Appropriations Act (Public Law 117-328) of 2023, which directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices.  

Click to download: Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance [ PDF - 1.17 MB]

Click to download: Federal Register Notice Announcing availability of the Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance [ PDF TBD]

Consistent with section 2505(c) of the Consolidated Appropriations Act, 2023, FDA solicited public comment on the Draft Report and Plan from a broad range of interested parties. The public comment period closed on March 4, 2024. Following the close of the public comment period, FDA prepared the final report and plan, available below.

Click to download: Food and Drug Administration Report and Plan on Best Practices for Guidance

 

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