FDA’s budget proposal include policy wish list

FDA’s FY27 budget proposal outlines a set of legislative priorities that would expand the agency’s authority and reshape key aspects of drug regulation. These include an expedited alternative to the IND pathway, permanent authorization of the rare pediatric priority review voucher program, changes to advisory committee structure, and efforts to streamline biosimilar regulation.

As BioCentury has reported, the proposed expedited IND pathway is an ambitious effort to reduce reliance on preclinical animal toxicology by incorporating non-animal models. Its impact, however, will depend on scientific validation of these approaches and FDA’s ability to operationalize them, which is likely to take years and may not address the reasons sponsors are increasingly choosing locations outside the U.S. for first-in-human trials...