Investigation & Intelligence Feeds
FDA rethinks need for comparative efficacy studies for certain biosimilars
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates t...
Examining the Beneficial Use and Regulation of Chemicals: U.S. Senate Committee on Environment & Public Works Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight Subcommittee Hearing
The Oversight Committee of the United States Senate Committee on Environment & Public Works held a hearing on October 23rd titled: ...
FCC Announces Tentative Agenda for November 2025 Open Meeting
Following a busy October agenda at the Federal Communications Commission (FCC or Commission) and despite the continuing government shut...
Recent Biologics Decisions at Health Canada
In the last few weeks, Health Canada issued several decisions concerning biologics. On October 17, Health Canada approved, via a Noti...
Defending the Algorithm™: A Bayesian Analysis of AI Litigation and Law PT 2
In this Defending the Algorithm™ blog and audio series, we've examined the important Bartz v. Anthropic copyright settlement, explored ...
Oklahoma enacts new licensing and compliance requirements for digital asset kiosk operators
On October 15, the Oklahoma State Banking Department issued a memo outlining new requirements stemming from the May 29 enactment of SB ...
The Northern District of California Calls on the California Legislature to Fix CIPA
The N.D.Cal. shared its frustration with the language of CIPA, the conflicting rulings on how it has been applied, and the need for the...
Double Trouble: Navigating ADA and Privacy Compliance in Website Policy Changes
Although New York and California remain epicenters for ADA and privacy-related website litigation, these issues are not confined to tho...
340B Program Alert: HRSA Approves Manufacturer Rebate Models for Pilot Program Participation
In a move that will fundamentally change how the 340B Drug Pricing Program (“340B Program”) operates for a subset of medications, HRSA’...
FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is...