How Ocular Therapeutix Recovered From US FDA’s Second Dextenza CRL

A new approach, total dedication and lots of practice made a difference for the Massachusetts start-up after FDA approval was twice deferred over manufacturing quality concerns.

Business disaster - Image
stunned by second complete response, firm revamped quality system • Source: Shutterstock

It was the second complete response letter from the US Food and Drug Administration that was so deflating for the people at Ocular Therapeutix Inc.

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