March 26, 2024

The U.S. Food and Drug Administration has made available a webinar intended to help developers and sponsors of animal biotechnology products learn more about how the agency reviews next generation sequencing (NGS) data submitted as part of an application, as well as how to electronically submit these data using the FDA’s precisionFDA platform. This webinar is another element in the FDA’s work to support and encourage the development of innovative products to improve human and animal health, as described in the agency’s Animal and Veterinary Innovation Agenda.

Developers are increasingly using NGS data to support the molecular characterization of intentional genomic alterations (IGAs) in animals, as these data may be utilized to confirm the IGA and identify any unintended alterations. As part of the review process, the FDA’s Center for Veterinary Medicine performs an independent analysis of the raw NGS data submitted by developers. This webinar provides an overview of that analysis and describes how to submit large NGS datasets to the agency in support of the molecular characterization of IGAs in animals. 

The webinar also covers the common types of NGS data; the general approach the FDA uses in its independent analysis of the NGS data; a description and demonstration of precisionFDA; and the steps for submitting NGS data to CVM using precisionFDA. 

For more information: 

• Intentional Genomic Alterations (IGAs) in Animals
• CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals
• precisionFDA
• Animal and Veterinary Innovation Agenda