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Taran March @ Quality Digest

FDA Compliance

Most Drug and Biological Product Makers Meet Postmarketing Requirements

Backlog of clinical trials from 2007 are either closed or underway

Published: Tuesday, November 30, 2010 - 17:13

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.

Under the FDAAA, the agency must annually report the status of the backlog of PMR and PMC for all approved drug and biological products. In addition, manufacturers of drugs and biologics are required to report to the FDA in a timely manner any serious safety issues that are identified from studies or other sources.

Key findings of the study include:

• During the second annual review, the status of 591 PMR and PMCs changed. Nearly half (46 percent) of the PMR and PMCs were updated to fulfilled status, which reflects a significant effort by FDA staff to complete reviews of the large number of submitted final reports identified during the first annual review. Those remaining were updated as a result of study or trial initiation and completion, final report submission, or missed milestone dates.
• Only 17 percent of the backlog of PMRs/PMCs were delayed
• Just 7 percent of PMRs and PMCs on schedule after the first annual review became delayed during the second review

For more information, see General Information on Postmarketing Requirements/Postmarketing Commitments.

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About The Author

Taran March @ Quality Digest’s picture

Taran March @ Quality Digest

Taran March is Quality Digest’s editorial director A 35-year veteran of publishing, she has written and edited for newspapers, magazines, book publishers, and universities. When not plotting the course of QD with the team, she can usually be found clicking around the internet in search of news and clues to the human condition.