Partner Michael Werner spoke with InsideHealthPolicy on the Food and Drug Administration's (FDA) release of two final guidances that provide clarification for cell and gene therapy developers on how their products can qualify for FDA expedited review programs. Developers can gain this expedited review through the use of novel clinical trial designs and historical controls and through the use of a common manufacturing protocol to group data from multiple developers and researchers.
Mr. Werner discusses specific examples and details in the newly released guidances to explain how trial design and the timing of a review decision should go a long way in helping the industry. Mr. Werner predicts that there will be more development in the regenerative medicine space as the FDA continues to release new guidances on the topic.
"FDA’s continued interest in providing clarity around its regulatory framework makes for an environment that’s conducive to the development of safe and effective products," Mr. Werner said. "It’s not a coincidence that more of these products will come forward as FDA does just that."
READ: FDA Guidances Expand RMAT Definition, Discuss Use of Novel Trials (Subscription Required)
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