Yogendra Narayanrao Keche*

Department of Pharmacology, All India Institute of Medical Sciences, Raipur, India

*Corresponding Author: Yogendra Narayanrao Keche, Department of Pharmacology, All India Institute of Medical Sciences, Raipur, India.

Received: September 04, 2023; Published: October 01, 2023

Abstract

The applicable government regulatory organizations’ final approval is required for the technology utilised for the preparation of PRP. The US Food and Drug Administration (FDA) does not regulate the injection of PRP because it is a technique. Through the 510(k) process, the FDA has approved a number of devices used to separate whole blood into PRP. Protein-rich plasma (PRP) and autologous chondrocyte/osteocyte implantation are not regulated by the Indian CDSCO and ICMR because they are classified as different cell-based applications.

References

1. Jeffrey A Tice. “Platelet-rich Plasma Injection for Achilles Tendinopathy: A Technology Assessment”.
2. National guidelines for Stem Cell Research (2017).
3. Knut Beitzel., et al. “US Definitions, Current Use, and FDA Stance on Use of Platelet-Rich Plasma in Sports Medicine”. Journal of Knee Surgery 28 (2015): 29-34.
4. CFR - Code of Federal Regulations Title 21, [Code of Federal Regulations] [Title 21, Volume 7][CITE: 21CFR640.34].
5. “Guidelines for the Use of Platelet Rich Plasma”. Presented by: The International Cellular Medical Society, DRAFT Version 1.0. Committee Members: Kim Harmon, MD, Ron Hanson, MD, Jay Bowen, MD, Scott Greenberg, MD, Ed Magaziner, MD, James Vandenbosch, David Harshfield, MD, Brian Shiple, MD, David Audley.
6. Adrian DKL., et al. “Current Clinical recommendations for Use of Platelet-Rich Plasma”. Current Reviews in Musculoskeletal Medicine 11 (2018): 624-634.

Citation

Citation: Yogendra Narayanrao Keche. “Regulatory and Ethical Concerns for the Research on Platelet Rich Plasma (PRP)". Acta Scientific Pharmacology 4.4 (2023): 01-02.

Copyright

Copyright: © 2023 Yogendra Narayanrao Keche. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.