An insightful webinar designed for pharmaceutical manufacturers responsible for meeting FDA compliance requirements across registration, reporting, and fee-based programs. Whether you’re entering the U.S. for the first time or recalibrating your approach, this session delivers a strategic, structured overview of what’s expected—and how to get it right from the start.

Topics covered:
– Establishment registration and product listing
– CARES Act amount reporting
– GDUFA self-identification and facility/user fees
– OMUFA facility fees
– Submission timelines and documentation expectations