Stay updated with breaking news from Approval Process. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
Documents released Wednesday by FDA clarifies the agency will continue to lead the regulatory review of intentional genomic alterations in animals, with information-sharing from the Agriculture Department on some products. The agency also released updated guidance for the industry on the risk-based approach and approval process of these products.
Agency established a MOU with USDA to clarify roles and responsibilities.
This document explains how FDA’s approval process applies to heritable intentional genomic alterations in animals.
/PRNewswire/ -- Today, the U.S. Food and Drug Administration took important steps to advance the FDA's regulatory process for intentional genomic alterations...
Agency established a MOU with USDA to clarify roles and responsibilities.