Overview of Regulatory Requirements for OTC Monograph Drugs
Presented by Victoria Pankovich
September 17, 2025, 1pm (eastern)
If you are considering entering the OTC monograph drug space, the challenges of FDA regulatory requirements can be confusing. With a mixture of regulations spanning pharmaceutical Good Manufacturing Practices (GMPs); prescriptive monographs categorized by therapeutic classes, covering labeling and claims; as well as registration and listing requirements, these nonprescription drug products are held to a variety of standards. When you factor in the requirements of the OTC Monograph Drug User Fee Program (OMUFA), and reporting requirements per the 2020 CARES Act it’s easy to become overwhelmed.
EAS will present a complimentary one-hour webinar Overview of Regulatory Requirements for OTC Monograph Drugs on Wednesday, September 17, 2025 at 1pm EDT to acquaint you with the regulations and offer a glimpse at where to find the information you need.
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About the Presenters
Victoria Pankovich
Manager, Regulatory Services
Reporting to the Senior Director Pharmaceutical & Medical Device Consulting, Victoria Pankovich supports clients through assembling and processing FDA submissions including Drug Master Files, Abbreviated New Drug Applications and New Drug Applications. Serve as the primary US Agent for all required communications with FDA on behalf of clients, including Establishment Inspection coordination with FDA, Drug, Medical Device and Food facilities registration; Drug and Medical Device product listings; Color Certification requests; FDA Inspection Notifications; FOl and FDA Controlled Correspondence requests.