US FDA Commissioner Scott Gottlieb believes the potential for "review efficiencies" will entice manufacturers to allow public posting of their clinical study reports (CSRs) after a drug application's approval.
Clinical Study Disclosures Will Make Drug Reviews More Efficient – Gottlieb
US FDA pilot program linking drug approval documents to sponsors' clinical study reports will improve review efficiency and access to information by medical researchers and drug developers, commissioner says; move also could aid sponsors when it comes to reimbursement decision-making, Foley and Lardner's Rosen predicts.
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