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D., Deakin, N
Observed Effects in Phase 3 Clinical Trials: Notably, these observations derive from Phase 3 human clinical trials with thousands of participants
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The 503A Bulks List is the mechanism that allows this kind of compounding, and a substance only lands on it after a full sequence: nomination, a PCAC recommendation like this one, a comment period, then formal rulemaking through the Federal Register
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