“Radical Transparency” at FDA: What Has It Meant in Practice?
June 24, 2026
29C
Type: Breakout Session
Focus Area:
Intellectual Property and Legal Landscape
Both Secretary Kennedy and Commissioner Makary have signaled that there will be a new era of “radical transparency” at the Food and Drug Administration (FDA). Regulatory transparency is generally desirable, particularly on matters of public health and the safety and efficacy of medicines for human use. As the FDA has undergone significant changes during the first year of the Trump administration, in the areas of personnel, organization, and interpretation of its mission, has the Agency lived up to its pledge? What has “radical transparency” looked like, and has it always been a good thing for patients and industry?
Session speakers will examine such developments as the use of expert panels in lieu of advisory committees, the public release of Complete Response Letters (CRLs), and the award of preferential review timelines via the Commissioner’s National Priority Voucher program through a transparency lens and offer their conclusions.
Speakers


