What’s New in OMUFA II?
Virtual
Wednesday, January 29, 2025
2:00 PM - 3:00 PM
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Eastern Standard Time
OMUFA II, the reauthorization of the legislation that defined OTC Monograph Reform, has been negotiated between industry and FDA and will soon be transmitted to Congress for consideration in 2025.
Webinar attendees will briefly hear about OMUFA I accomplishments and then will hear the specifics of changes coming in OMUFA II, including processes and user fees. CHPA will also provide highlights of the FDA public meeting on November 20th, where stakeholders provided feedback to FDA on plans for OMUFA II. This webinar is intended for those familiar with OMUFA I and OTC regulations. CHPA speakers David Spangler, Mike Bailey and Barb Kochanowski participated in the negotiations for OMUFA II and will be pleased to answer member questions following the presentation.
Speakers
David Spangler, Senior Vice President, Legal, Government Affairs & Policy
Mike Bailey, Senior Vice President Regulatory & Scientific Affairs
Barbara Kochanowski, Senior Vice President, Special Projects