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FDA Reports on Good Guidance 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.

Click to download: 2011 Report on Good Guidance Practices: Improving Efficiency and Transparency (PDF- 138 KB)

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: 2023 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

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

View the Fact Sheet for Good Guidance Practices

 

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