In late 2017, the FDA put out a complete policy framework for regenerative medicine therapies. This press release features Dr. Peter Marks:
FDA Media Briefing on FDA’s Comprehensive Policy Framework for the Development ofRegenerative Medicine ProductsNovember 16, 2017 - https://www.fda.gov/media/108940/download
Peter Marks is quoted on p.9 confirming that post approval requirements may be satisfied by clinical trials or patient registries or other real world evidence as agreed with the agency.
Until now, Dr. Perin had assumed that a confirmatory trial will be required for Revascor for heart failure for advanced HFrEF patients. Is this going to change if it is approved for end stage HFrEF patients via the Accelerated Approval pathway the agency has guided the company to discussing, as the company expects to do this half of the year?
Is the answer not in black and white on p. 9 of the document?
Cell Therapy News/Articles, page-17818
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