BIO Comments on FDA Guidance: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
On Tuesday, September 13th, BIO submitted comments in response to the FDA’s recent draft guidance on voluntary consensus standards (VCS) for regenerative medicine therapies.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.