Comment from California Institute for Regenerative Medicine
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Summary: The California Institute for Regenerative Medicine (CIRM) expresses strong support for the FDA's proposed Expedited Investigational New Drug (IND) Pilot Program. They argue that the program's Qualified Research Institution (QRI) model is well-suited for complex therapies like regenerative medicine and offer specific recommendations on qualifications, oversight, and success metrics based on their experience managing the CIRM Clinical Network.
On behalf of the California Institute for Regenerative Medicine (CIRM) and the CIRM Clinical Network, thank you for the opportunity to submit comments in response to the Request for Information on the Expedited Investigational New Drug (IND) Pilot Program. We are strongly supportive of the Food and Drug Administration’s proposed Expedited Investigational New Drug (IND) Pilot Program and we offer the attached comments to support its success.