Bulk Drug Substances Currently Under Review

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<div class="col-md-8 col-md-push-2" role="main"><p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b45b0ef1-0125-4a25-ba85-aaa4725f433e" title="List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species">List of Bulk Drug Substances for Compounding…

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Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present

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<div class="col-md-8 col-md-push-2" role="main"><p><a name="top"></a>As required by 505A(k)(1) and 505B(h)(1) of the Federal Food, Drug, &amp; Cosmetic Act (BPCA and PREA, respectively), the following are the medical, statistical, and clinical…

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