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.
You may also be interested in...
US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.
Only 15% of postmarketing commitments for drugs approved in 2009-2012 were for clinical trials and only half of these were published, study finds; authors call for US FDA to provide more trial information.