Section

Clinical Trials

Trial conduct and oversight: BIMO inspections, investigator letters, debarments, eligibility and trial-design guidance.

9 stories

Regulatory News has published 9 Clinical Trials stories between 15 July 2026 and 10 October 2026, each sourced to the primary record — the Federal Register entry, the Official Journal notice, the guidance document or the regulator’s own release — and written and edited by Connor Griggs, the publication’s editor. Last updated 10 October 2026.

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Showing 9 of 9 stories

Four colleagues shake hands and smile in a bright office setting

Clinical Trials EMA Makes Pre-CTA Trial Advice Pilot Permanent Oct 10, 20265 min read Read the story

Two colleagues shake hands across a table in a bright office

Clinical Trials FDA Opens Docket on Ibogaine Trial Design, Safety Oct 7, 20265 min read Read the story

A surgical team works together under bright operating lights during a vascular procedure

Devices & Diagnostics Medtronic Wins FDA Breakthrough Tag for Below-Knee PAD Oct 5, 20265 min read Read the story

A nurse holding a tablet consults with a colleague in a bright white clinic hallway

Drugs & Biologics FDA Approves Gazyva for Childhood Nephrotic Syndrome Sep 28, 20266 min read Read the story

A woman in an office reviews a paper case folder beside a tall stack of aged file records and a laptop

Clinical Trials FDA Warns Investigator Over Trial Drug Accountability Aug 13, 20265 min read Read the story

A judge in black robes signs a document at a wooden desk beside a statue of Lady Justice and a gavel

Clinical Trials MHRA Plans a 14-Day First Review for Phase 1 Trials Aug 4, 20265 min read Read the story

A researcher in a hairnet and lab coat looks through a benchtop microscope while adjusting its focus knob

Clinical Trials FDA Debars Research Site Owners Who Faked Trial Data Aug 3, 20265 min read Read the story

A loose pile of white, oblong pharmaceutical tablets spread across a light blue background

Clinical Trials FDA Finalizes Three Cancer Trial Eligibility Guidances Jul 30, 20265 min read Read the story

The Food and Drug Administration sign above the entrance to the agency's headquarters

Clinical Trials FDA's Psychedelics Guidance Is Final, After Three Years Jul 15, 20265 min read Read the story