FDA: Most post-marketing studies meet timelines

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Makers of approved drugs and biologics generally are meeting their regulatory obligations and completing their post-marketing studies in a timely manner, according to a report released Sept. 3 by the FDA.

A review of 1,531 open post-marketing studies indicated that more than 80 percent are proceeding according to established timelines, have been submitted for FDA review or have been determined by the FDA to have met their goals or are no longer needed.

The study, conducted by Booz Allen Hamilton and supported by additional funds from Congress, examined the backlog of industry post-marketing studies for FDA-approved drugs and biologics. The review found that most companies meet their obligations in a timely manner.

The study recommended changes designed to improve the quality of the information submitted to the FDA, the timeliness of the FDA review and the accuracy of the FDA’s databases.

The agency is evaluating the recommendations and has made significant improvements based on the study, including:

  • Establishment of a post-marketing study development coordinator and a tracking coordinator within each new drug division;
  • Development of new manuals of policies and procedures for development of post-marketing studies and tracking the status of post-marketing studies; and
  • Creation of a new post-marketing study database in the document archiving and records retention system that includes increased capabilities for data capture, tracking and generating reports related to post-marketing studies. The system was implemented at the end of July.

“The data indicate that makers of approved drugs and biologics are generally meeting their regulatory obligations and are on track with their studies. To date, we have not identified any previously unknown serious safety issues from the submitted final study reports,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.