Replication Is Dead. Corroboration Is the Standard Clinical Trials Must Meet Now.
The NEJM just reframed reproducibility in biomedical science, and every clinical trial sponsor still designing for repetition is building...
DOGE FDA Budget Cuts
The FDA Created an AI Office. Now Comes the Hard Part.
CDER's new Office of Innovation and Clinical Trial Modernization fuses AI and RWE policy under one roof. That structural...
FDA’s 2026 Single-Trial Default Standard Reframes the Dual-Pivotal Debate for Sponsors Still Designing Phase 3
FDA's 2026 shift to a single pivotal trial as the default approval standard forces sponsors to rethink Phase 3...
FDA Hears 80 Speakers on Psychedelic Drug Therapy Standards
The FDA held a public hearing on psychedelic drug therapy, drawing more than 1,800 registered attendees and 80 speakers...
The Oregon Dataset Is Larger Than the Entire History of Psychedelic Trials. So Why Are Regulators Still Looking the Other Way?
OHSU's 2,363-person Oregon psilocybin dataset dwarfs every RCT in the field's history. Here's what it tells us that clinical...
Intellia’s CRISPR Submission Is a Regulatory Stress Test the FDA Has Never Faced Before
Intellia's nex-z BLA for ATTR amyloidosis is the FDA's first in vivo CRISPR reckoning—and the agency's gene therapy playbook...
AI Platform Predicts Clinical Trial Outcomes with High Accuracy
At the Clinical Trial Innovation Summit 2025 in Basel, QuantHealth's Chief Medical Officer presented AI-driven trial simulation technology capable...