May 24, 2021

Virtual Session on Animal Biotechnology to be Held by FDA

Virtual Session on Animal Biotechnology to be Held by FDA

The United States Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has announced a virtual Animal Biotechnology Stakeholder Outreach Session that is open to the public. The Meeting will take place June 28, 2021, from 3:40 pm - 4:45 pm Eastern Time. The session is available for no cost and is in conjunction with the Genome Writer’s Guild 2021 Conference.

The meeting will emphasize enhancing the predictability, transparency, and efficiency of the review process for the intentional genomic alterations (IGAs) in animals. These are animals whose genomes have been intentionally altered using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal. 

The Veterinary Innovation Program (VIP) is available to most developers of IGAs in animals and is aimed at facilitating advancements in the development of innovative animal products by providing greater certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to approval. 

At the session, CVM will discuss its science- and risk-based approach for IGAs and will provide a brief overview of the agency’s risk analysis and review process. The session will conclude with a breakout group of listening and feedback sessions, where stakeholders are encouraged to provide their input.  

Those interested in the meeting can register here. Feedback may also be emailed.