FDA To Unveil Regenerative Medicine Regulatory Framework In September

In September FDA will unveil a comprehensive framework detailing how the agency plans to regulate and oversee regenerative medicine through a series of guidance documents aimed at streamlining agency policies to help manufacturers demonstrate safety and effectiveness, Commissioner Scott Gottlieb announced Friday (July 7). The agency chief also noted FDA's biologics center is continuing to implement the new Regenerative Medicine Advanced Therapy (RMAT) designation for certain medical products in order to speed development and approval of novel therapies to bring...