The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."
Eyenovia's late-stage study for near-sightedness in children with an experimental drug-device combination has been discontinued after failing to slow myopia progression, leading to consideration of strategic alternatives.
The agency did not agree with Regeneron’s proposal to add dosing intervals greater than every 16 weeks, the maximum interval currently indicated for aflibercept 8 mg injections.
Retinal Physician
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