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Regenerative Medicine Clinical Trials: US FDA Supports Studies Comparing Multiple Agents

 
• By Brenda Sandburg

Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.

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The US FDA is encouraging the use of adaptive clinical trial designs for regenerative medicine therapies, such as having sponsors study several investigational agents together for treatment of rare diseases.

The Center for Biologics Evaluation and Research describes its views on clinical trial designs in a

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