Regulatory evidence shifting from statistics to mechanism — an acknowledgement that n=1 medicine needs a different standard.
Development
FDA proposes approving personalized medicine without randomized trials
Claim
The FDA proposed a plausible mechanism pathway to approve personalized medicines without randomized controlled trials.
Reporting date: (not necessarily the event date)
Sources
Attribution and reporting linked by this record; links do not imply independent verification.
- Welcome to December 14, 2025 (theinnermostloop.substack.com)
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