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Negocios · 3/2/20061 min de lectura
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
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Resumen
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 AMARYL (glimepiride), MOBIC (meloxicam), NORVIR (ritonavir), and NOVOLOG (insulin aspart). 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 de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →