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USFDA Guidance: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This Small Entity Compliance Guide is intended to help small entity establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) better understand the comprehensive regulatory framework for HCT/Ps, outlined in part 1271 of Title 21 of the Code of Federal Regulations.


This guide provides section-wise questions & answers related to Registration & Listing, Donor eligibility, Current Good Tissue Practice, FDA inspection, etc.


Click this LINK to know in detail about the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).


Also yesterday (31-October-2022) USFD released draft guidance "Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials" which is intended to assist sponsors in monitoring growth and, when appropriate, pubertal development in clinical trials that enroll pediatric participants with rare and common diseases.


This guidance provides recommendations for measuring growth and recording pubertal development for evaluating safety.



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