📊Public Briefing on AI Diffusion Framework
On January 10, 2025, the Office of the Federal Register posted for public inspection a Bureau of Industry and Security (BIS) interim final rule: "Framework for Artificial Intelligence Diffusion" (RIN 0694-AJ90). This document announces that, on January 15, 2025, BIS will host a virtual public briefing on this rule. This document also provides details on the procedures for participating in the virtual public briefing.
Learn More🤖New Export Controls Impacting AI Technology and Business Compliance
With this interim final rule, the Commerce Department's Bureau of Industry and Security (BIS) revises the Export Administration Regulations' (EAR) controls on advanced computing integrated circuits (ICs) and adds a new control on artificial intelligence (AI) model weights for certain advanced closed-weight dual-use AI models. In conjunction with the expansion of these controls, which BIS has determined are necessary to protect U.S. national security and foreign policy interests, BIS is adding new license exceptions and updating the Data Center Validated End User authorization to facilitate the export, reexport, and transfer (in-country) of advanced computing (ICs) to end users in destinations that do not raise national security or foreign policy concerns. Together, these changes will cultivate secure ecosystems for the responsible diffusion and use of AI and advanced computing ICs.
Learn More🤖FDA Draft Guidance on AI Use in Drug Regulation Available for Comments
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products." In accordance with its mission of protecting, promoting, and advancing public health, FDA's Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Oncology Center of Excellence (OCE), the Office of Combination Products (OCP), and the Office of Inspections and Investigations (OII), is issuing this draft guidance to provide recommendations to industry on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding the safety, effectiveness, or quality for drug and biological products.
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