Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment."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.
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