Regulatory Dashboard | Navigating FDA’s Guidance on Potency Assurance for Cellular and Gene Therapy Products

The FDA’s Office of Therapeutic Products recently introduced a draft guidance document titled “Potency Assurance for Cellular and Gene Therapy Products .”

This guidance offers recommendations for developers of human cell and gene therapy products (referred to as CGT products) on how to establish strategies for controlling the potency of these complex products. The guidance differentiates from the previous one released in 2011 and titled “Potency Tests for Cellular and Gene Therapy Products focused exclusively on the development of potency assays. As a reflection of advancements and learnings in the CGT field, the draft guidance, once finalized, will supersede and replace the 2011 one.

 

Written by Lara Stevanato, PhD, Ergomed Associate Director of Regulatory Affairs, Biologics and ATMPs

Please enter your details to get access to the resource








    This site uses cookies to personalize and customize your experience. By clicking “I Accept", you consent to cookies in accordance with our privacy policy.

    Privacy Settings saved!
    Privacy Settings

    When you visit any web site, it may store or retrieve information on your browser, mostly in the form of cookies. Control your personal Cookie Services here.


    • wordpress_test_cookie
    • wordpress_logged_in_
    • wordpress_sec

    Decline all Services
    Accept all Services
    Secured By miniOrange