US: FDA tries to prep stem cell clinics for upcoming enforcement

13-06-2019

US: FDA tries to prep stem cell clinics for upcoming enforcement

(Source: RAPS 2019-06-14)

The three-year grace period for not enforcing premarket approval requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps) is more than half over, and the US Food and Drug Administration (FDA) said Wednesday that it has not received the responses from manufacturers that it expected.

To combat this lackluster response rate from HCT/P manufacturers, including stem cell clinics, the agency is launching a temporary program (ending at the end of the year) to help companies obtain a rapid, preliminary, informal and non-binding assessment from FDA regarding how the HCT/Ps will be regulated. The agency said it intends to respond to inquiries that contain enough detail for evaluation within three days of receipt, as resources permit.

Acting FDA Commissioner Ned Sharpless said in a statement: “The pace of progress of those offering these human cells, tissues, and cellular and tissue-based products, including stem cell treatments, to come into compliance with the requirements has been slower than expected. It’s possible some stakeholders have questions about the requirements or length of the process.”

But some believe that because FDA already has several other ways for industry to obtain information on the regulatory status of their HCT/Ps, the new temporary program, called the TRG Rapid Inquiry Program (TRIP), may not be useful.

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