10/19/18: The letter relates to Ocular’s compliance with data collection and information reporting obligations in a post-approval Device Exposure Registry study required as a condition for approval of the premarket approval (PMA) application for ReSure® Sealant.
Outstanding items pertain to Form FDA-483 close-out of manufacturing deficiencies and analytical testing
No efficacy or safety issues raised by FDA
Ocular TherapeutixTM, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for...
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