Transparency: FDA to release more info on premarket reviews
The FDA on Wednesday sought comments on a new effort to provide more clarity on the agency’s pharmaceutical application review and decision-making process.
FDA highlighted two efforts for which it’s seeking further comment: A fledgling pilot program launched in January 2018 that sought to provide more transparency on sponsors’ clinical study reports (CSRs) but only resulted in the release of one CSR, and a new integrated review template, currently being implemented, that can better convey the FDA’s analysis and decision-making in drug approvals.
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