OMOR Or Not To OMOR: Proposals Will Push US OTC Monograph Fees Past Requested Level

Payments FDA receives could expand from facility fees between $13,548 and $20,322 collected from around 1,700 firms for the current fiscal year to include payments of $500,000 or $100,000 from firms for proposed monograph changes.

OTC monograph drug program user fees the US Food and Drug Administration requested for fiscal year 2022 are up slightly from the agency’s current budget, but the total amount it collects in the 12 months starting October could be much larger.

More from Archive

More from HBW Insight