Drug Sponsors Are On Schedule With Most Post-Approval Studies
US FDA's Gottlieb touts use of real world evidence as report shows vast majority of postmarketing requirements and commitments progressing on schedule.
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About 80% of drug sponsors were on track with post approval studies in FY 2017, US Food and Drug Administration notes in its annual report on performance of applicants.
US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.
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.