FDA Launches Elsa 4.0; Completes Agency-Wide Data Consolidation
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 data platform consolidation that brought more than 40 disparate data sources, systems, and portals into a single platform called HALO (Harmonized AI & Lifecycle Operations for Data). The agency is […]
When the AI Gets It Wrong: Accountability Doesn’t Transfer
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 batch testing, inadequate quality unit oversight. The kind of cGMP failures that have been showing up in Warning Letters for decades. But this had something different. In the middle of […]
Direct to Consumer Telehealth: An Enforcement Warning Shot
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 to kickbacks. The ruling has significant implications for pharmaceutical and biotech companies. In U.S. v. Regeneron Pharmaceuticals Inc., the court introduced a tougher “but-for causation” standard that could reshape how the government and […]
FCA Kickback Ruling: What It Means for Pharma and Biotech
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 the report, high prescription conversion rates, limited clinical encounters, payment structures, and patient data flowing back to manufacturers could be viewed as remuneration intended to induce prescribing of federally reimbursable drugs. […]