Bulletin 19-4

FDA Announces the New TRG Rapid Inquiry Program (TRIP)

On June 12, 2019, the FDA notified the American Association of Tissue Banks (AATB) about the new TRG Rapid Inquiry Program (TRIP) page published on the FDA website.

The Program will operate as part of FDA’s Tissue Reference Group (TRG), and will help manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including those stakeholders that market HCT/Ps to physicians or patients, to obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated. The TRIP is a temporary program of the TRG, effective June 12, 2019 - December 31, 2019.

If you have questions about TRIP, you may send them to industry.biologics@fda.hhs.gov.

The following webpages may also be helpful:

Please contact Dr. Roman Hitchev at hitchevr@aatb.org if you have any other questions or concerns.