The expected nominee for FDA commissioner has not been very kind to the agency in his public statements and President-elect Donald Trump appears to be urging him to shake things up.
New US Food and Drug Administration commissioners have something of a tradition of offering some fulsome praise for the agency staff at the beginning of their tenure.
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Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.
Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
