Input on Draft Report, Plan on Developing New Guidances Sought by FDA

The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances.

After issuing a similar report in 2011, “Food and Drug Administration Report on Good Guidance Practices Improving Efficiency and Transparency”, the agency says it “has made significant strides to modernize and enhance our best practices for the efficient initiation, prioritization, development, review, clearance, and issuance of our guidance documents.

As a part of the 27-page draft report and plan, “Draft Report and Plan on Best Practices for Guidance,” the agency says it “is also considering opportunities to further improve our guidance development and review and clearance practices, streamline processes for regulatory submissions to FDA through issuance of guidance documents, and implement innovative guidance development processes.” Comments on the draft report are due by March 4.

Read the draft report here.

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