FDA Transparency Initiative

FDA Commissioner, Dr. Margaret A. Hamburg, launched FDA’s Transparency Initiative in June 2009.  The Transparency Initiative has proceeded in three phases:

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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.

• Summary of Phase II 
• Progress Report of Phase II

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.

• Summary of Phase III
• Progress Report of Phase III

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Continued Efforts

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.  FDA encourages the public to review the report, and it is accepting comments until Feb 28, 2012.  More...

Transparency Reports on Compliance and Enforcement Activity

• On January 31, 2012, FDA released a new report presenting eight initiatives adopted by the Commissioner to explore avenues for making FDA’s compliance and enforcement data more accessible and user-friendly.
  More...
• On October 3, 2011, FDA released a report that contains eight draft proposals to improve access to FDA's compliance and enforcement data.
  More…

Phase II/Phase III Implementation

FDA is working diligently to implement the action items and many of the draft proposals in the Phase II and Phase III Reports. The Commissioner is still considering the public comments on certain draft proposals, as well as their feasibility.

FDA invites the public to track our progress by clicking on the links to the Phase II and Phase III Progress Reports, above.