What FDA’s July 2026 Psychedelic Drug Guidance Actually Says About Trial Design
FDA's finalized psychedelic guidance rewrites the rules on blinding, informed consent, and session monitoring, and the NEJM's September 2026...
Remote Informed Consent
When the Consent Form Is the Catastrophe: What Alembic’s FDA Warning Letter Means for Your Site
Alembic's July 2026 FDA warning letter on informed consent failures at its Vadodara BE facility exposes the GCP documentation...
The Informed Consent Warning Letter Every Site Director Should Read Twice
FDA's July 2026 warning letter to Alembic's bioequivalence site exposes informed consent failures that can ground any trial. Here's...
The Consent Form Doesn’t Cover the Data: A Gap Regulators Can No Longer Ignore
Nature Medicine flags data rights as consent's missing pillar—and three converging signals show the FDA's frameworks haven't caught up...