OTC-ing New Pathways: An OTC Update
July 28, 2026 | 2:00PM–3:30PM ET | Live Webinar
Overview
FDA’s Additional Condition for Nonprescription Use (ACNU) pathway has provided a new route for FDA to approve OTC drugs since the rule went into effect in May 2025. In this webinar, experts will examine the impacts and implications of this new pathway, provide an update on recent and forthcoming prescription-to-OTC switches, and discuss proposed OTC monograph amendments and administrative orders—including through the lens of patient access. The program will also examine practical considerations surrounding the use of the ACNU pathway and its potential implications for the future of OTC drug development. Attendees will gain valuable insights into this evolving regulatory landscape and the considerations that may shape future OTC drug strategies.
Speakers
Kim Boyd
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Principal, Leavitt Partners, LLC
David Spangler
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Senior Vice President, Legal, Government Affairs & Policy, Consumer Healthcare Products Association (CHPA)
Elisabeth Walther
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Associate Director for Strategic Initiatives, Office of Nonprescription Drugs (OND), Center for Drug Evaluation and Research (CDER), FDA
Moderated By Liz Guo
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Special Counsel, Covington & Burling LLP
FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.
