Not admitted · Normative
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 23 Nov 2024 · owen-1342
Quote
Normative
“The more FDA can incorporate post-marketing data into approval requirements, the better. It shunts funding away from too expensive clinical trials that capture only a tiny subset of the population. It moves therapeutic development towards broader population health-level surveillance as essential.”
Letter to Dr. Makary, section 'What to Change at FDA'. Recommendation to use post-marketing data in approval requirements, with claimed consequences: funding shifts away from expensive trials and development moves toward population-level surveillance.
'Should', 'must', 'ought to', 'needs to' with no predictive reading.