FDA Ends Program to Assist Cellular Therapy Manufacturers With HCT/P Assessments

April 07, 2021

The Food and Drug Administration ended the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP) on March 31. The program allowed manufacturers of human cells, tissues, and cellular and tissue-based products (HCTPs) to obtain a rapid, preliminary, informal, non-binding assessment from the agency regarding how it regulates specific HCT/Ps.

Manufacturers who would like to obtain information about the regulatory status of an HCT/P may submit a request to FDA’s Tissue Reference Group for informal recommendation process; through the Request for Designation (RFD) process for a formal agency decision from FDA’s Office of Combination Products; or through the Pre-RFD process, which is used to obtain preliminary feedback from OCP on the HCT/P classification.