top of page
Search

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

Writer's picture: Sharan MuruganSharan Murugan
Nov 1, 20221 min read

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Also yesterday (31-October-2022) USFD released draft guidance "Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials" which is intended to assist sponsors in monitoring growth and, when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.



 
 
 

Comments

I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page