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PostMarketing Commitments November 26, 2010

Posted by Michael Hamrell in Regulatory Thoughts.

More and more drug manufacturers are now required or agreeing to complete additional studies after approval of their drug product by the FDA. These postmarketing studies may be required as a condition of approval or agreed to by a sponsor to address additional issues, but not required by statute or regulation.

The FDA recently issued their 2nd Annual report on the status of the postmarketing studies for drug and biologic products. The FDA is required to report annually on the status of the postmarketing studies, as outlined in FDAAA from 2007. The report was completed by Booz Allen Hamilton for FDA. According to the report that covered over 1500 studies, 40 percent of the postmarketing studies/clinical trials had been closed (either fulfilled or released) by FDA. Of the remaining 60 percent, most were in progress and on schedule or the final report has been submitted for FDA review.

The information about postmarket requirements and commitments comes from Agency letters and from annual status reports submitted by applicants. According to the FDA, the information will be verified for accuracy before it is posted on the Web site, that is supposed to be completed ever quarter. Only 17% of the backlog of PMRs/PMCs were now considered delayed.


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