Archive for February, 2012

Report on Exploratory Program to Increase Access to the Agency’s Compliance and Enforcement Data

February 17, 2012 13 comments

Recently, the FDA released a report titled, “Food and Drug Administration Transparency Initiative: Exploratory Program to Increase Access to the Agency’s Compliance and Enforcement Data.” that identified eight new initiatives adopted by FDA Commissioner Margaret A. Hamburg, M.D. to explore ways to increase the transparency of FDA’s compliance and enforcement data.  These initiatives are based on draft proposals FDA released on October 3, 2011, as well as on comments the public submitted in response to those proposals.

Focused on making the compliance and enforcement data FDA receives and generates more accessible and user-friendly, these initiatives are part of FDA’s ongoing efforts to enhance the public’s understanding of the Agency’s decisions and promote accountability of the Agency and industries it regulates. 

Commissioner Hamburg launched FDA’s Transparency Initiative in June 2009.  The report issued recently, which advances that initiative, is part of FDA’s response to President Obama’s Presidential Memorandum on Regulatory Compliance, which directed federal agencies to make compliance information more publicly available, easily accessible, downloadable and searchable online.  A task force of key FDA leaders overseeing the Transparency Initiative endorsed all the specific initiatives presented in this latest report. 

We invite the public to review the Agency’s progress in implementing other action items and draft proposals related to the Transparency Initiative at:

Daniel Sigelman

Senior Policy Advisor and Transparency Initiative Coordinator

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