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.
The first guidance is intended to spell out more clearly when cell- and tissue-based products are excepted from the established regulations if they are removed from and implanted into the same individual within the same surgical procedure and remain in their original form. The guidance is …