Start with a testable clinical need
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🧠A practical regulatory question starts with the clinical need a therapy could address.
At ARDD 2026, FDA speakers discussed development around defined conditions and functional decline without first requiring aging itself to be designated a disease. Speakers also described planned regulatory-science attention to aging and longevity. These were discussions of priorities and development approaches, not a new approval pathway.
The useful next questions are concrete: which population, which meaningful outcome, and what evidence of benefit and safety? A broad aging hypothesis still needs a precise clinical question.
#ARDD2026 #Geroscience #ClinicalTrials #Healthspan
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🧠At ARDD, FDA speakers discussed defined clinical needs and function without first designating aging a disease. The next questions: which population, which outcome, what benefit–risk evidence? This is not a new approval pathway. #ARDD2026 #Geroscience
Credit: Michael DeStefano
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