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A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments

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Abstract

This article outlines the current process for tracking and reporting postmarketing commitments (PMCs) by the US Food and Drug Administration (FDA). In addition, it summarizes a recent Pharmaceutical Research and Manufacturers of America (PhRMA) company survey on PMCs and offers recommendations for improving the accuracy of the information available to the public on the status of PMCs.

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References

  1. Food and Drug Administration Modernization Act of 1997. Available at http://www.fda.gov/cber/genadmin/fdamod97.pdf. Accessed March 13, 2007.

  2. Food and Drug Administration. Postmarketing studies for approved human drug and licensed biological products; status reports. Food and Drug Administration website. Available at http://www.fda.gov/OHRMS/DOCKETS/98fr/103000c.htm. Accessed March 13, 2007.

  3. Postmarketing study commitments. Food and Drug Administration website. Available at http://www.fda.gov/cder/pmc. Accessed March 13, 2007.

  4. Postmarketing Study Commitments Working Group. Guidance for industry: reports on the status of postmarketing study commitments—implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997. Food and Drug Administration website. Available at http://www.fda.gov/cder/guidance/5569fnl.htm. Accessed March 13, 2007.

  5. Office of New Drugs. Procedures for completing and processing the form “Annual Report Review: Postmarketing Study Commitment Summary.” Food and Drug Administration website. Available at http://www.fda.gov/cder/mapp/60042.pdf. Accessed March 13, 2007.

  6. Pediatric use information. 63 Federal Register 66670 (1998) (codified at 21 CFR §314.55[b]).

  7. Department of Health and Human Services. Office of Inspector General. FDA’s monitoring of postmarketing study commitments (OE1-01-04-00390), June 2006. Office of Inspector General website. Available at http://oig.hhs.gov/oei/reports/oei-01-04-00390.pdf. Accessed March 13, 2007.

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Correspondence to Michelle Folz MSN.

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Folz, M., Bokelman, M., Hassall, T.H. et al. A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments. Ther Innov Regul Sci 42, 23–26 (2008). https://doi.org/10.1177/009286150804200105

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  • DOI: https://doi.org/10.1177/009286150804200105

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