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The Department of Homeland Security’s new rule eliminating “duration of status” for F, J and I nonimmigrants will have significant implications for healthcare organizations that sponsor and train international physicians.

The U.S. Food and Drug Administration has released a discussion paper outlining its initial framework for regulating generative AI-enabled medical devices, proposing a two-axis risk assessment approach and a novel competency-based premarket evaluation system. With public comments due by October 19, 2026, this represents a critical opportunity for device manufacturers and stakeholders to shape the regulatory landscape for this transformative technology.

The FDA has released new draft guidance establishing a comprehensive risk-based framework for evaluating container closure systems used in pharmaceutical packaging, marking a significant update from its 1999 guidance. This framework addresses five critical factors including material safety, environmental protection, performance standards, manufacturing impacts, and storage considerations, with particular emphasis on leachables assessment and quality control programs across different drug delivery routes.