ARTICLE | Regulation

FDA’s Woodcock reflects on aducanumab, drug approval standards, the future of clinical trials

Acting FDA Commissioner Janet Woodcock reflects on the past and future of drug development

June 16, 2021 10:44 PM UTC

Acting FDA Commissioner Janet Woodcock has more experience as a drug regulator than any of her predecessors — and she has arrows in her back to prove it. While her decades of experience provide fodder for critics, they also inform her decisions with a perspective that crosses therapeutic disciplines and incorporates lessons from successes and failures over decades in which science and regulation have undergone immense changes.

In a wide-ranging conversation with BioCentury, Woodcock discussed the standards FDA applies to medical product approvals, suggested that the U.S. should consider creating a mechanism for the government to direct clinical research in emergencies, and called for faster progress on creating a learning healthcare system. ...