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[DOI] [PMC free article] [PubMed] [Google Scholar] 31.Tan H.C., Dampil O.A., Marquez M.M

Both pathways required that the bulk drug substance either appear on FDA's approved list or be a component of an FDA-approved drug

However, its important to note that 24 weeks, while substantial for clinical trials, represents a relatively limited timeframe for assessing lifetime exposure safety