Trendpublic

⚖️New Export Controls on Biotechnology Equipment for Businesses

With this interim final rule (IFR), the Bureau of Industry and Security (BIS) is revising the Export Administration Regulations (EAR) to address the accelerating development and deployment of advanced biotechnology tools contrary to U.S. national security and foreign policy interests. This rule institutes new controls on certain biotechnology equipment and related technology. It further solicits public comments on the changes it implements.

🐾FDA Guidance on Type VII Veterinary Master Files for R&D Released

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This draft guidance, when finalized, will describe FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.

🏥Upcoming NIH Meeting on Grant Applications for Health Research

🧬FDA Guidance on Genomic Alterations in Food-Producing Animals

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #251 entitled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease." This draft guidance, when finalized, will set forth FDA's policy regarding heritable intentional genomic alterations (IGAs) in animals of food- producing species, such as swine and rabbits, that are intended to be marketed for use as models of human or animal disease in biomedical research under contained and controlled conditions. The draft guidance describes the conditions under which we generally may not expect developers of IGAs in animal models of disease to submit an application to FDA's Center for Veterinary Medicine (CVM) or to get our approval before marketing their animals following CVM's prior review of risk factor data.

🧬FDA Guidance on Heritable Genomic Alterations in Animals

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This guidance clarifies FDA's requirements and recommendations for developers of intentional genomic alterations (IGAs) in animals. The guidance is one of two companion documents. "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the FDA approval process applies to heritable IGAs in animals. The companion final guidance, GFI #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals.