Janet Woodcock has been in the lead in the commissioner race for months without an announcement, but now serious doubts are being cast on her candidacy, including the tone of remarks at a White House press briefing.
The imminent departure of US Food & Drug Administration Principal Deputy Commissioner Amy Abernethy is clearly a loss of leadership for an agency already living through an uncertain transition period, but does leave open the ability for the next commissioner (whether it is Acting Commissioner Janet Woodcook or another nominee) to choose a number two that reflects that individual’s priorities.
Woodcock announced Abernethy’s intention to leave FDA in a 23 March email to staff. In an interview...
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
