Investigation & Intelligence Feeds
Use of AI In Decision-Making May Jeopardize Employees’ FLSA Exempt Status
As artificial intelligence becomes more prevalent in workplaces, it may have an unexpected impact upon employers. While employers may ...
Social Links: Robots, Rewinds, and a Rocky Mountain High
A new bipartisan bill introduced in the U.S. Senate would make it illegal for minors to use “companion” AI chatbots, with criminal pena...
FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05
On November 2, 2025, the FDA issued a complete response letter (CRL) for Alvotech’s abbreviated Biologics License Application (aBLA) fo...
The BR Privacy & Security Download: November 2025
Welcome to this month’s issue of The BR Privacy & Security Download, the digital newsletter of Blank Rome’s Privacy, Security &...
EC Requests Scientific Opinion on the Safety of Hydrated Silica (Nano), Pyrogenic Silica (Nano), Silica Silylate (Nano), and Silica Dimethyl Silylate (Nano)
The Scientific Committee on Consumer Safety (SCCS) announced on October 30, 2025, that the European Commission (EC) requested a scienti...
The Fiscal Year 2026 National Defense Authorization Act: Where We Are And What’s Next
The National Defense Authorization Act (NDAA) is the annual bill to authorize funding, policies and programs for the U.S. national secu...
Sustainable Density in the Age of AI
The relentless demand of artificial intelligence is fundamentally restructuring the energy industry. The term “energy transition” inade...
AI-Powered Scams Are on the Rise: What You Need to Know and How to Protect Yourself
Artificial intelligence (“AI”) continues to transform society in ways beyond imagination. It is rapidly becoming clear that AI pervad...
Rare Disease Focus: FDA’s Trio of Cell and Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs, and Postapproval Evidence Generation
FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are de...
Regulatory & Risk Advisory Review: Cayman Islands – July to September 2025
Welcome to our current edition of our Regulatory & Risk Advisory Review. This issue dives into regulatory shifts and emerging trend...