Leaders of FDA’s oncology center say sponsors could initiate a single randomized trial prior to receiving accelerated approval or conduct a single-group AA study concurrently with a randomized trial. FDA and sponsor could agree in advance on criteria for approval and withdrawal.
Leaders of the US Food and Drug Administration’s Oncology Center of Excellence say sponsors can more readily obtain evidence to confirm or refute the clinical benefit of drugs granted accelerated approval by conducting a randomized trial prior to obtaining approval.
In a New England Journal of Medicine
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
