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  • Print publication year: 2012
  • Online publication date: July 2012

Chapter 2 - Regulatory issues

Suggested reading

Hamburg, M. A. and Sharfstein, J. M. (2009). The FDA as a Public Health Agency. New Engl J Med, 360 (24), 2493–5.
Piantadosi, S. (1997). Clinical Trials: A Methodologic Perspective. New York: John Wiley & Sons.
Woodcock, J. (2009). A difficult balance – pain management, drug safety, and the FDA. New Engl J Med, 361 (22), 2105–7.
FDA Website
Supporting information:
The U.S. Food and Drug Administration (2004). Innovation/Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products. March 2004.
Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS). REMS Assessments and Proposed REMS Modifications.
General Accounting Office report, FDA Drug Approval: Review Time Has Decreased in Recent Years, http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm117257.htm

The views are those of the author and not necessarily those of the Food and Drug Administration.

Supporting information:

The U.S. Food and Drug Administration (2004). Innovation/Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products. March 2004.
Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS). REMS Assessments and Proposed REMS Modifications.
General Accounting Office report, FDA Drug Approval: Review Time Has Decreased in Recent Years, http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm117257.htm

The views are those of the author and not necessarily those of the Food and Drug Administration.