Tele: 561.316.3330
Breaking Medical Device News

Friday, October 15, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeOcular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix™ Reports FDA Warning Letter Related to ReSure® Sealant

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.

Ocular Therapeutix™ Receives Complete Response Letter from FDA for DEXTENZA™ NDA

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...

By using this website you agree to accept Medical Device News Magazine Privacy Policy