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Entreprise · 03/02/20031 min de lecture
Draft Guidance for Industry on Nonclinical Safety Evaluation of Pediatric Drug Products; Availability
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Résumé
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Nonclinical Safety Evaluation of Pediatric Drug Products." The draft guidance provides recommendations on the role and timing of animal studies in the safety evaluation of therapeutics intended for the treatment of pediatric patients.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →