Strategies, Tools & Talent for What’s Next! In our final session of the series, we’ll focus on setting your organization – and your career – up for success in the year ahead. We’ll discuss how compliance drives business impact, how…
FDA: Agency Deploys Agentic AI Capabilities for Staff Use
FDA: Agency Deploys Agentic AI Capabilities for Staff Use
December 5, 2025/
The U.S. Food and Drug Administration announced the rollout of agency-wide agentic AI tools designed to support employees with complex, multi-step tasks. These systems build on the FDA’s earlier deployment of its LLM-based tool, Elsa—currently used voluntarily by a majority of staff—and introduce more advanced features for workflow automation, planning, and reasoning. Participation remains optional, with human oversight built into all applications. The enhanced AI capabilities are expected to aid activities such as meeting coordination, pre-market reviews, post-market surveillance, inspections, compliance activities, and general administrative functions.
Related Posts
USTR: U.S. and U.K. Reach Agreement on Pharmaceuticals and Medical Technology
On December 1, 2025, the United States and United Kingdom announced a new agreement on pharmaceuticals, pharmaceutical ingredients, and medical technology. Under this arrangement, the U.S. would remove Section 232 tariffs on U.K.-sourced medical goods, pause any Section 301 investigations related to U.K. pharmaceutical pricing during President Trump’s term, and collaborate to expand U.K. patient…
CBP: Section 321 Enforcement Update in ACE to Block Ineligible De Minimis Shipments
CBP is enhancing Section 321 enforcement within ACE to ensure compliance with the $800 de minimis threshold. Starting June 26, the update will be deployed to the CERT environment. This enhancement will prevent the release of shipments claiming de minimis entry when the $800 per person per day limit has already been exceeded, helping to…
OFAC: GVA Capital Fined $216M for Russia Sanctions Violations
The Office of Foreign Assets Control issued a penalty notice for almost $216M on GVA Capital Ltd. They’re a venture capital firm in California. This is for violating the Russia sanctions and failing to comply with a subpoena. Read More
Justice: DOJ Declines to Prosecute PE Firm After Voluntary Disclosure of Export Violations
The United States Department of Justice declined to prosecute a private equity firm after they discovered criminal violations of export laws that one of their acquired companies had committed and disclosed them voluntarily. Read More