Proposed PDUFA Reauthorization (Federal Register, January 16, 2007)

Institute of Medicine report: The Future of Drug Safety: Promoting and Protecting the Health of the Public (2006)

New England Journal of Medicine perspective: "Protecting the Health of the Public - Institute of Medicine Recommendations on Drug Safety," by Bruce M. Psaty, MD, PhD, and Sheila P. Burke, MPA, RN (October 26, 2006)

Government Accountability Office report: Drug Safety: Improvements Needed in FDA's Postmarket Decision-making and Oversight Process (March 2006)

Testimony of Steven E. Nissen M.D., FACC at the House Committee on Energy and Commerce Hearing "The Adequacy of FDA to Assure the Safety of the Drug Supply," February 13, 2007

Transcript of former FDA commissioners' panel discussion (provided by Kaisernetwork.org) held at George Washington University on February 21, 2007 as part of SKAPP's "Strengthening the FDA" program

Draft paper from Daniel Carpenter: “Deadline Effects in Regulatory Drug Review: A Methodological and Empirical Analysis,” presented at SKAPP's FDA policy workshop on February 22, 2007.

Presentation by David Feigal regarding resources at the FDA, presented at SKAPP's FDA policy workshop on February 22, 2007.

Marcia Angell's Boston Globe op-ed, "Taking back the FDA," February 26, 2007

Jerry Avorn's Boston Globe op-ed, "Merck's multibillion-dollar bet," February 18, 2007

White paper on PDUFA, "Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA Budget, and Drug Safety Related?" from the George Washington University School of Public Health and Health Services

Jerry Avorn's NEJM perspective, "Paying for Drug Approvals — Who's Using Whom?", New England Journal of Medicine, April 13, 2007