Posted by Michael Wonder on 26 Feb 2017
FDA officials defend agency's flexibility under current regulatory framework
24 February 2017 - Top officials at the US FDA are defending the agency's flexibility to accelerate the availability of products by considering diverse data sources in product submissions.
In an article in Nature Reviews Drug Discovery on Friday, Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, writing alongside former FDA Commissioner Robert Califf and other high-ranking agency officials, argue that misconceptions about the agency's ability to assess data from diverse sources, including real-world data, contributes to the so-called "evidence gap" between the data used to support regulatory approval and the data needed to inform clinical decision-making.
According to the authors, "widely held views that current regulatory structures cannot accommodate a modern, robust and diverse evidence base, and that these regulatory structures are predicated on narrowly targeted premarket evaluations of medical products," hinder progress toward generating data that could more accurately reflect a product's real-world use.
