Breaking: FDA Announces Program to Help Manufacturers of HCT/Ps Understand Regulatory Pathways for Specific Products

The U.S. Food and Drug Administration is announcing a temporary program called the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), which will operate as part of FDA’s Tissue Reference Group.

The program will assist manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including those stakeholders that market HCT/Ps to healthcare professionals and/or patients, obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated.

The agency intends to respond to inquiries that contain sufficient detail for evaluation within three days of receipt, as resources permit. The program will be available until December 31, 2019.

View full FDA announcement:

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-announces-temporary-streamlined-program-help-manufacturers-human-cell-tissue-and

Source: U.S. FDA