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.
- FDA Report on Good Guidance Practices: Improving Efficiency and Transparency
- Fact Sheet on Good Guidance Practices