Rx Roundup: FDA & Beyond

Research evidence excerpt

Rx Roundup: FDA & Beyond

TD Cowen

Global Research May 15, 2026

development of promising new treatments for unmet needs.” The effort reinforces the

expectation that a major theme of the Prescription Drug User Fee Act reauthorization

process will be responding to the emergence of China as a leader in first-in-human studies

by addressing perceived barriers to clinical trials in the US. Please see the healthcare

sections (starting page 12) of our China Report to learn more about these efforts and the

PDUFA reauthorization as an underappreciated event and opportunity for policies to limit

China's reach and accelerate US leadership in biopharma.

■Plausible Mechanism. FDA is reviewing “about 150 comments” on plausible mechanism,

CBER Associate Director for Policy Phil Kurs told the Food and Drug Law Institute annual

conference May 7. FDA released the draft guidance on the new framework in February,

and the comment period closed April 27. The number of responses is “quite a lot for a draft

guidance,” Kurs noted. “Of the ones that I've reviewed thus far, they seem to generally

be positive in terms of supporting the idea behind the plausible framework,” he said. In

addition, “there are definitely comments asking us to provide additional recommendations

or to add additional products to the ones that we discussed in the draft guidance.” FDA has

also been making an effort to clarify elements of the guidance – including the idea that it is

a “framework” rather than a “pathway,” and that a “plausible” mechanism does not simply

mean a hypothetical one – in both internal and external meetings.

■FDA Division of Hematologic Malignancies 2 Director Gormley Departing after 13 years

with agency including seven as head of DHM 2. Nicole Gormley has also been the Oncology