Postmarketing Commitments: Sponsors Often Do Not Publish Results Of New Clinical Trials
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.
You may also be interested in...
US FDA's Gottlieb touts use of real world evidence as report shows vast majority of postmarketing requirements and commitments progressing on schedule.
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.
US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.