Unfunded Elements of House User Fee Draft Would Bog Down Drug Reviews: Woodcock

CDER Director Janet Woodcock is urging House lawmakers not to overload their omnibus user fee draft with unfunded mandates that would add unneeded “work strain” to the resource-strapped FDA, including a requirement that would expedite manufacturing changes to speed shortage drugs to market. Draft language proposing changes to the FDA’s mission statement, and talk of requiring federal certification of online pharmacies, would likewise redirect agency personnel away from product reviews, Woodcock said at a House Energy and Commerce Committee Health Subcommittee hearing Wednesday.
Drug Industry Daily