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Event Website

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Event Details

This 2-day hybrid workshop will explore the evolving landscape of generic ophthalmic drug products, where increasing formulation complexity and innovative delivery systems present unique challenges for ensuring therapeutic equivalence and quality. Designed as a collaborative platform, the workshop brings together FDA scientists, industry leaders, and academic experts to share knowledge, discuss regulatory expectations, and identify research priorities that support safe, effective, and affordable ophthalmic generics.

Participants will gain critical insights into formulation sameness, physicochemical characterization, bioequivalence strategies, and quality considerations for ophthalmic solutions, dispersions, inserts, implants, and drug-device combination products. Sessions will feature expert presentations, case studies, and interactive panel discussions.

Choose your experience:

Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person only) working sessions. Virtual attendees will be able to:

• Attend all presentations and panel discussions
• Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
• Enjoy free access to workshop recordings of presentations and panel discussions (not including the in-person only sessions)

In-person Attendees will enjoy all the benefits of virtual attendance as well as interactive experiences featuring:

• Interactive Working Sessions on key topics related to generic ophthalmic drug products, such as compositional sameness, bioequivalence demonstration strategies, drug release testing, quality, and devices, with FDA, industry, and academic experts.
• Collaborative Problem-SolvingExercises, including real-world case studies and consensus mapping to identify priorities and actionable outcomes.
• for clarifying regulatory expectations and exploring regulatory standards insights.
• Networking Opportunities designed to foster partnerships and advance regulatory science for complex ophthalmic generics.

For more information, visit the Center for Research on Complex Generics website.

FDA Resources

1. GDUFA Science and Research
2. Generic Drug Development
3. GDUFA III Reauthorization
4. Pre-ANDA Program
5. Product-Specific Guidances for Generic Drug Development
6. Guidances Related to Generic Drugs (under topics, choose “generic drugs”)