House of Representatives to Address OTC User Fees

Last month we reported OTC Monograph User Fees, Pre-submission Meetings and Electronic Submissions Possible and included our latest paper entitled FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions. We noted that although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become law. On September 13, CQ Roll Call reported that a bi-partisan measure has been initiated in the US House of Representatives.  Click here for the full story. Contact us for help with OTC monograph changes.