Placeholder Banner

BIO Comments on FDA Guidance: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

September 13, 2022

On Tuesday, September 13th, BIO submitted comments in response to the FDA’s recent draft guidance on voluntary consensus standards (VCS) for regenerative medicine therapies. In the comment letter, BIO expressed appreciation to FDA for issuing a guidance on this topic along with support for VCS, as they are a necessity for ensuring product quality and patient safety. Furthermore, BIO stated that VCS will accelerate the development of regenerative medicine, which encompasses a set of complex and rapidly evolving technologies, by making it easier for developers to comply with FDA regulations and enabling them to better compare different strategies for manufacturing cell and gene therapy (CGT) products. BIO additionally noted that CDRH’s long running VCS program is widely considered a success and demonstrates the feasibility and advantages of this approach. BIO additionally presented several recommendations for how the Agency could further strengthen the program. For example, ensuring that standards evolve with emerging science, manufacturing, and clinical experience (in the RMT field). Additionally, modality-specific considerations (e.g., AAV vectors versus CAR-T cells) should be considered when developing VCS that apply across all RMTs.

Download Full Comments Below
BIO Comment Letter VCS Recognition Program for Regen Med Therapies
Discover More
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on…
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how…
On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what…