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More than 80% of pharmaceutical and biologics companies are completing their postmarketing studies and regulatory obligations in a timely manner.
More than 80% of pharmaceutical and biologics companies are completing their postmarketing studies and regulatory obligations in a timely manner. The finding is a result of a new US Food and Drug Administration study performed under contract with Booz Allen Hamilton and supported by Congress that reviewed 1531 open postmarketing studies submitted by pharmaceutical firms.
“New resources and directives from Congress have allowed us to complete this long-desired review,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research in press release. “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.”
The study included recommendations as to how companies may improve the quality of the information they submit FDA, the timeliness of the FDA review, and the accuracy of the FDA’s databases, including:
The agency says it will continue to work with Booz Allen Hamilton to complete its review of all submitted reports in a timely manner.