Opinion: Rigorous clinical trials improve stem cell safety

01/22/2013 | The Scientist online

FDA oversight and requirements for rigorous clinical trials will help ensure future stem cell therapies are safe and effective, which will in turn help research organizations develop more therapies, writes Aastrom Biosciences interim CEO Dan Orlando. The FDA has already developed streamlined approval processes for breakthrough and critical drugs, and clinical investigators should work more closely with industry and regulators to further streamline the process, Orlando writes. "A rigorous clinical trial system and regulatory oversight are key to protecting patients, improving care, and bringing much-needed therapies to patients and the physicians that care for them," he concludes.

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