Cook Myosite Blog

Webinar: Lessons Learned from RMAT Submission, Denial, and Successful Resubmission

Posted by Cook MyoSite on Sep 14, 2021 11:48:51 AM

In this webinar, originally presented via RegMedNet on April 15th, 2021, the Regulatory experts at Cook MyoSite walk attendees through the company's experience applying for the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, receiving an initial rejection, and reapplying to successfully obtain the designation.

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Topics: regenerative medicine, clinical development, clinical trials, regulatory