Enhancing Research and Development Approaches for FDA Approval of Ophthalmic Products

Abstract

This article offers a detailed overview of the regulatory journey for ophthalmic therapeutic products in the U.S., focusing on safety, efficacy, and quality assurance. It covers pre-investigational New Drug (IND) meetings, Investigational New Drug (IND) applications, clinical and nonclinical development processes, and the intricacies of New Drug Application (NDA) filing. Special attention is given to Emergency Use IND, Investigator-Sponsored IND, and Treatment IND applications. The discussion extends to Biologics License Applications (BLAs) for diverse ocular medications. Emphasis is placed on post-market surveillance in Phase 4 trials, underlining the commitment to continual monitoring of drug safety and efficacy. Pharmaceutical manufacturers navigating the approval process for ophthalmic therapeutics will find this article to be a valuable and insightful resource.