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

 
• By Bowman Cox

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.

As with the first, it said the New Bedford, MA, company of less than 200 employees had still not shown it would be able to properly manufacture its proposed new...

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