The legal and regulatory landscape in life sciences moves fast. The companies that navigate it best are the ones that see it coming.
This is where we share what we’re watching: regulatory shifts, enforcement trends, launch readiness considerations, and the operational moments that create legal exposure when no one’s paying attention.
Legal Update: On May 6, 2026, FDA announced the launch of Elsa 4.0, a major upgrade to the agency’s internal AI assistant, alongside the completion of a
On April 2, 2026, FDA issued a Warning Letter to Purolea Cosmetics Lab in Livonia, Michigan. The letter cited the usual things you’d expect: insanitary conditions, failed
Four U.S. Senators have released the results of a nine-month investigation into direct-to-consumer (DTC) telehealth arrangements linked to pharmaceutical brand sites. Their findings? According to
In a pivotal decision, the U.S. Court of Appeals for the First Circuit has raised the bar for proving False Claims Act (FCA) violations tied
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