Healthy Skepticism Library item: 13614

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies
Washington, DC: US Food and Drug Administration 2008 Apr 24
http://www.fda.gov/cder/pmc/default.htm

Abstract:

The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by applicants of approved drug and biological products. This is the agency’s report on the status of the studies applicants have agreed to or are
required to conduct…

This report summarizes the status of postmarketing commitments as of September 30, 2007…

Notes:

From Federal Register / Vol. 73, No. 80 p.22157-9/ Thursday, April 24, 2008 / Notices

Click on .pdf labelled FY2007 at FDA link for numbers of studies not yet initiated, ongoing, delayed etc.