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FDA Transparency Initiative Overview

The FDA launched a Transparency Initiative in June 2009.  The Transparency Initiative had three phases. More information, reports, and progress reports are available in the FDA Archive.

Phase I: FDA Basics - In January 2010, FDA launched a web-based resource called FDA Basics, which provides the public with basic information about FDA.

Phase II: Public Disclosure - In May 2010, the Task Force released the Phase II Transparency Report, which focused on disclosing certain information about FDA-regulated products and firms.

Phase III: Transparency to Regulated Industry - In January 2011, the Task Force released the Phase III Transparency Report, which focused on increasing the transparency of FDA operations and decision-making.

FDA implemented the action items and many of the draft proposals in the Phase II and Phase III Reports.

Transparency Report on Compliance and Enforcement Activity

  • On April 22, 2014, FDA released a report recommending ways to enhance the transparency and public accessibility of the agency's compliance and enforcement data.

Report on Good Guidance Practices

In December 2011, FDA issued a report focused on improving the transparency and efficiency of the Agency's guidance development processes.

 More Information



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