Despite recent headlines targeting Johnson & Johnson’s uncorrected manufacturing problems and deficiencies, most makers of approved drug and biological products are meeting their regulatory obligations and targets for postmarketing studies and clinical trials in a timely manner, according to a study released by the U.S. Food and Drug Administration (FDA).

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

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

 …