The FDA has issued two final guidances and two draft guidances, all designed to articulate the agency’s approach to developing and overseeing novel cellular therapies and other regenerative medicine products.
The agency said its suite of four guidance documents constituted a risk-based and science-based policy framework approach designed to support innovative product development while clarifying the FDA’s authority, its enforcement priorities against products deemed to raise potential significant safety concerns.
The two final guidances are designed to clarify the FDA’s interpretation of the risk-based criteria manufacturers must use to determine whether a product is subject to the FDA’s premarket review.
“This field is dynamic and complex. As such, it has presented unique challenges to researchers, healthcare providers, and the FDA as we seek to provide a clear pathway for those developing new therapies in this promising field, while making sure that the FDA meets its obligation to ensure the safety and efficacy of the medical products that patients rely upon," FDA Commissioner Scott Gottlieb, M.D., said in a statement.
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