2023-03949: Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment." This guidance is intended to provide recommendations to sponsors developing drugs intended to treat neovascular age-related macular degeneration focusing on eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to foster greater efficiency in development programs.
The agency’s own summary, as published.
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