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

Why Participate in a Clinical Trial?

Posted by Cook MyoSite on Aug 30, 2021 11:47:50 AM
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Why participate in a clinical trial?

Clinical trials are studies in which new treatments (drugs, devices, or biologics) are tested using human volunteers. These potential new treatments might be tested against the efficacy of another treatment intended for the same condition, be tested against a placebo, or against an untreated group (more on that in our previous post). Clinical trials provide the necessary rigorous testing of a treatment before it is approved for use in the general population.  

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Topics: clinical development, clinical trials