COVID-19 UPDATE: Regenexx is committed to the health and safety of our patients. You may now be seen in clinic or via telemedicine for virtual/online or phone visits.
LEARN MORE
Our physicians are available via telemedicine to continue to give you the care you need during this difficult time. Learn more.

More Cells=Drugs Updates

By /

Receive a Regenexx® Patient Info Packet by email and learn why it's a superior regenerative solution.

By submitting the form, you are agreeing that you read and consent to our Privacy Policy. We may also contact you via email, phone, and other electronic means to communicate information about our products and services. We do not sell, or share your information to third party vendors.

Cells=Drugs - Regenexx

More updates on Cells=Drugs – Regenexx.  The journal Translational Medicine just published an editorial entitled: Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor’s new clothes. The full paper is here. Here’s the abstract:

ABSTRACT: FDA has recently asserted that many autologous cell therapies once considered the practice of medicine are in fact drugs. These changes began with the creation of new sections of 21 CFR 1271 and a subsequent one word change where the FDA, without public commentary, altered a single word in its regulatory language regarding cell and tissue based therapies that asserted the authority to classify autologous tissue as drugs. The bright line between medical care and drug production can be delineated in many ways, but a simple metric that defines the dichotomy is the consent status of the patient. In healthcare, a patient can either be consented individually for a medical procedure or exposed to an unconsented risk where regulatory assurances are already in place. These new FDA policies apply rules meant to keep drugs safe in a drug factory (unconsented mass production risks) to individually consented surgical procedures. We argue that there is little societal benefit to these changes and that they are already stifling medical innovation.

Category: Latest News

Is Regenexx Right For You?

Request a free Regenexx Info Packet

REGENEXX WEBINARS

Learn about the #1 Stem Cell & Platelet Procedures for treating arthritis, common joint injuries & spine pain.

Join a Webinar

RECEIVE BLOG ARTICLES BY EMAIL

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Subscribe to the Blog

CONTACT US

9035 Wadsworth Pkwy #1000
Westminster, CO 80021
888-525-3005

FOLLOW US

Copyright © Regenexx 2020. All rights reserved. | Privacy Policy

*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.

LinkedIn
Email