The draft document, which was dated April 10 and labeled “pre-decisional,” appears to come from the Office of Management and Budget. Known in budgetary parlance as a passback, it outlines the Trump administration’s priorities for the agency. The Washington Post first reported on the document’s existence.
User fees, which are collected by the FDA from drug and medical device manufacturers, are expected to continue through the 2026 fiscal year, according to Grossman’s reading of the document. User fees made up about 69% of the FDA’s $2.34 billion budget for human drugs work in fiscal 2024. The document claims the preliminary budget would provide “sufficient budget authority levels to meet statutory requirements necessary for FDA to collect medical product user fees in support of its premarket review activities.”
Politico’s Agency IQ reported earlier this month that, due to the Trump administration’s laying off of thousands of staffers, the FDA risked hitting a “trigger,” whereby the FDA could be required to refund industry fees if spending by the agency falls below a certain level. READ MORE
by Elise Reuter
Source: biopharmadive.com
According to a study conducted by the company that included more than 600 participants, samples collected with the Teal Wand were shown to be just as accurate as those taken by a clinician during an office visit. About 94% of participants said they would opt for self-collection in the future, and 86% said they felt they would be more likely to stay up to date with cervical cancer screening if they could do it at home.
Jeremy Walsh was named head of IT and AI, according to his post on LinkedIn. The move was first reported by Politico. Walsh previously held the role of chief technologist at Booz Allen Hamilton, managing AI- and cloud-based projects for 14 years at the consultancy.
The new organization features two Business Groups that will rely on dedicated teams and assets to fully focus on meeting customer and market needs. Isabelle Bouvier is appointed as CEO of the Health & Pharma Solutions Business Group and Pascal Leroy as CEO of the Nutrition & Bioindustry Business Group. Béatrice Totel replaces Isabelle Bouvier as CFO of Roquette.
