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Negócios · 07/08/20071 min de leitura
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
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Resumo
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ACTIQ (fentanyl), ALDARA (imiquimod), AMBIEN (zolpidem), COREG (carvedilol), PROVIGIL (modafinil), and ZYPREXA (olanzapine). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →