Background: Report on Good Guidance Practices

As part of the Transparency Initiative, FDA is announcing the availability of a report entitled “Food and Drug Administration Report on Good Guidance Practices:  Improving Efficiency and Transparency.”  This report was prepared in response to Action Item 11 in the Phase III Report (FDA Transparency Initiative:  Improving Transparency to Regulated Industry, dated Jan. 2011).  In that action item, FDA's Commissioner, Dr. Margaret A. Hamburg, called for a cross-Agency working group to prepare a report identifying FDA’s “best practices” and making 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: Report on Good Guidance Practices: Improving Efficiency and Transparency (PDF 138 KB)

View the Fact Sheet for Good Guidance Practices