Abstract
The understanding and use of best regulatory practices is essential to advancing innovation in drug development. The following series of white papers analyze best practices for communication between FDA and applicants, special protocol assessments, advisory committees, and postmarketing commitments, as well as assessing industry implementation of good review management practices.
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References
Food and Drug Administration. Improving Innovation in Medical Technology: Beyond 2002. Available at: http://www.fda.gov/bbs/topics/news/2003/beyond2002/report.html. January 2003.
Food and Drug Administration. Innovation Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. Available at: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html. March 2004.
Food and Drug Administration. Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products. Available at http://www.fda.gov/cder/guidance/5812 fnl.pdf. April 2005.
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Maher, J.M. Introduction: PhRMA’s Best Practices Initiative on FDA’s Good Review Management Practices. Ther Innov Regul Sci 42, 1–2 (2008). https://doi.org/10.1177/009286150804200101
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DOI: https://doi.org/10.1177/009286150804200101