At public workshop, FDA says it will be flexible on clinical outcome assessments but stakeholders want agency to specify no-no's; digital health technology is appropriate to get more accurate endpoints, agency says.
Sponsors want the US FDA to specify the best practices to pursue in patient-focused drug development and in what instances the agency will not be flexible. That was one of the messages that came out of a two-day public workshop intended to help the agency develop a series of guidances.
The Oct. 15-16 meeting was specifically focused on the methods used to identify what is important to patients, and the methods to select, develop or modify fit-for-purpose clinical outcome assessments...
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
