BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 19/09/2008

Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document (GFI 187) entitled "Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs." This draft guidance is intended to clarify FDA's requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The draft guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA's intent to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. Elsewhere in this same issue of the Federal Register, the Animal and Plant Health Inspection Service (APHIS) is soliciting public comment on any potential implications of activities such as the importation or interstate movement of GE animals on the health of the U.S. livestock population under the authority of the Animal Health Protection Act (AHPA).

Source: Federal Register — Food and Drug AdministrationOpen original release →