US FDA says majority of drug and biological product makers meeting post-marketing requirements and commitments

Most makers of approved drug and biological products are meeting their regulatory obligations and meeting targets for post-marketing studies/clinical trials in a timely manner, according to a study released by the US Food and Drug Administration yesterday.

The study, based on the second annual review of the status of 1,551 post-marketing studies/clinical trials, showed that 40% of the post-marketing studies/clinical trials had been closed (either fulfilled or released) by the FDA. Of the remaining 60%, most were in progress and on schedule or the final report has been submitted for FDA review.

The review, carried out under a contract with Booz Allen Hamilton, examined the backlog of industry post-marketing studies and clinical trials for FDA-approved drugs and biologics. The backlog was defined as all those post-marketing requirements (PMR) and post-marketing commitments (PMC) open when the Food and Drug Administration Amendments Act (FDAAA) was enacted on September 27, 2007.