Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.
Total annual user fees of $22m to $34m from OTC manufacturers – primarily from facility registrations – are among the proposals in a discussion document circulated by Sens. Johnny Isakson, R-GA, and Bob Casey, D-PA.
Fees would also be raised when companies request changes via the monograph system. While the proposal does not detail the amounts collected from registering manufacturing facilities with FDA versus requesting...
Same-day announcements of RFIs from HHS secretary cover nutrient review process for infant formula and Kennedy’s “10-to-1 deregulatory policy” as part of president’s “broader federal effort to reduce regulatory burdens and increase transparency.”
Germany’s Federal Institute for Risk Assessment says that there is "no evidence that people with androgenetic alopecia have special dietary needs or a special nutrient requirement.”
After National Advertising Division attorneys, in a review prompted by a challenge by Band-Aid line marketer Kenvue, recommended ASO LLV cease use of its “up to 2x faster healing” claim, they determined the firm had not fully complied.
