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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

FDA Releases Report on Access to Agency Compliance Data

February 3, 2012—The U.S Food and Drug Administration (FDA) Jan.  27 announced in an advance Federal Register notice the availability of a report entitled “Food and Drug Administration Transparency Initiative: Exploratory Program to Increase Access to the Agency's Compliance and Enforcement Data.” The report, which was published Feb. 1, is part of the FDA’s Transparency Initiative, intended to enhance the public’s understanding about FDA activities and open avenues of communication by increasing the accessibility of its compliance and enforcement data in a web-based format.

The report lists eight initiatives recommended by the Transparency Task Force that the agency will explore, including: improving data quality; facilitating timely data disclosure; facilitating easier reporting; and offering compliance tools focused on error reporting. The FDA Commissioner adopted all eight proposals and the agency committed to examining additional measures to help prevent misinterpretation or misuse of the compliance and enforcement data that it publically discloses.

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org