Zdrowie i gospodarka · 16/01/2009

Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs; Availability

The Food and Drug Administration (FDA or the agency) is announcing the availability of a guidance for industry 187 entitled "Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs." This guidance is intended to clarify FDA's requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA's intent to exercise enforcement discretion regarding requirements for certain GE animals.