FDA Regulatory Pathway

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An Open Letter to Acting Commissioner Diamantas: The FDA Needs a Regulatory Pathway for Vaccine-Based Dementia Prevention Trials Now

Nature Medicine just made the case for large-scale RCTs of live-attenuated shingles vaccination for dementia prevention. Acting Commissioner Diamantas,...

By Moe Alsumidaie
June 19, 2026

The EMPHASIS Trial Correspondence Surfaces Three Trial Design Constraints That Will Shape the Next Neuroprotection Protocol

A Lancet correspondence on EMPHASIS identifies patient selection limits, generalisability gaps, and statistical design issues that every stroke trial...

By Moe Alsumidaie
June 9, 2026

Semaglutide’s Alcohol Data Is Stronger Than Anyone Expected — and the FDA Has No Playbook for It

A landmark Lancet RCT shows once-weekly semaglutide cuts alcohol use in obesity patients with AUD. The FDA's regulatory pathway...

By Moe Alsumidaie
May 4, 2026

Moe Alsumidaie

Chief Editor

An Open Letter to Acting Commissioner Diamantas: The FDA Needs a Regulatory Pathway for Vaccine-Based Dementia Prevention Trials Now

The EMPHASIS Trial Correspondence Surfaces Three Trial Design Constraints That Will Shape the Next Neuroprotection Protocol

Semaglutide’s Alcohol Data Is Stronger Than Anyone Expected — and the FDA Has No Playbook for It