In a previous post, we discussed the history of regenerative medicine from the 8th century B.C. through the present day. This exciting field has developed from its speculative roots into a broad and diverse industry with many subcategories and hundreds of therapies in development. In this post, we’ll talk about where exactly Cook MyoSite’s Autologous Muscle Derived Cells (AMDC) technology fits under the modern regenerative medicine umbrella.
Topics: regenerative medicine, clinical development, clinical trials, regulatory
Developing endpoints for regenerative medicine: an interview with Stephen Westover
This article was originally published to RegMedNet on June 16th, 2020.
Topics: regenerative medicine, clinical development, clinical trials, regulatory
Webinar: Lessons Learned from RMAT Submission, Denial, and Successful Resubmission
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.
Topics: regenerative medicine, clinical development, clinical trials, regulatory