Postmarketing study delays increase, but Gottlieb hopeful on progress

Despite a slight slip in numbers for on-schedule postmarketing studies, FDA Commissioner Scott Gottlieb sounded a positive note when he reported the agency's progress in holding companies accountable. In a statement Friday, he also said the agency is committed to adopting tools to capture real-world evidence in the postmarket setting and will soon publish a framework on the use of RWE.

In a FY17 report released Friday, FDA said 81% of postmarketing requirements and 76% of postmarketing commitments are on schedule. Those numbers were 85% and 77% in FY16, respectively. ...