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# FDA Launches Tissue Inquiry Program
- URL: https://www.fdaweb.com/fda-launches-tissue-inquiry-program/
- Published: 2019-06-12T12:00:00.000Z
- Updated: 2026-09-15T01:32:21.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144315

The FDA Tissue Reference Group (TRG) is launching a six-month TRG Rapid Inquiry Program (TRIP) to 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, obtain a rapid, preliminary, informal, non-binding assessment from FDA regarding how specific HCT/Ps are regulated. A program [description](https://www.fda.gov/vaccines-blood-biologics/trg-rapid-inquiry-program-trip?ref=fdaweb.com) says there currently are multiple ways in which stakeholders can learn about HCT/P regulatory pathways.

“In November 2017, FDA announced its [comprehensive regenerative medicine framework](https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/framework-regulation-regenerative-medicine-products?ref=fdaweb.com),” the description says. “At that time, [FDA also announced](https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework?ref=fdaweb.com) that until 11/2020, the agency generally intends to exercise enforcement discretion for certain HCT/Ps, with respect to FDA’s IND and premarket approval requirements, when the use of the product does not raise reported safety concerns or potential significant safety concerns. However, since the framework was announced, FDA has seen only modest progress by regulated industry in coming into compliance. Therefore, FDA is announcing the TRIP program of the TRG, for regulated industry to rapidly obtain a preliminary assessment from FDA as to how their HCT/Ps are appropriately regulated. As resources permit, FDA intends to provide preliminary, informal, non-binding responses within three business days after receiving an inquiry that contains sufficient detail for evaluation.”

The FDA post discusses submission of TRIP requests and the nature of agency responses.

Commenting on the new initiative, FDA acting commissioner **Ned Sharpless** said, “We remain firmly committed to advancing an efficient path for the safe and effective development of regenerative medicine products and to help foster beneficial new innovations. However, we also know there are many cases of companies making unsubstantiated claims about the potential for human cells, tissues, and cellular and tissue-based products to prevent, treat, or cure serious diseases, and in those cases, we are committed to taking action and protecting patients.”