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FDA raises concerns about cross-linking system in complete response letter to Avedro
Avedro received a complete response letter from the FDA regarding the new drug application for its riboflavin ophthalmic solution/KXL system for corneal cross-linking, according to a press release.In the letter, the FDA stated that it has identified a “small number of areas on the application” that require additional information concerning the device, but none of which pertains to the clinical study safety or efficacy data presented in the application, the release said.