FDA ends CSR pilot, plots new approach for disclosing study reports
The FDA on Thursday officially ended a fledgling pilot program that was part of an effort to provide more transparency on the drug approval process. The agency said it’s working on a new approach to disclosing study reports.
Last June, the agency was already pushing away from the clinical study report (CSR) pilot because of lackluster participation (FDA noted that Janssen was the only sponsor that agreed to participate) and said it would focus its efforts to better communicate the basis for drug approvals on the development of new integrated review documents.
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