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FDA Commissioner Marty Makary put it directly: "When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need." [1] The proposal is open for public comment through June 29, 2026

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Within-subject changes for etravirine concentrations (before and after 14-day efavirenz intake period) were assessed by calculating geometric means (GMs) and geometric mean ratios (GMRs) and 90% confidence intervals (CIs)

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