Cette traduction est en cours de préparation. En attendant, nous affichons temporairement la version originale en anglais.
Entreprise · 19/01/20111 min de lecture
Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Size of Beads in Drug Products Labeled for Sprinkle." This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).
Langue originale de la source: Federal Register — Health and Human ServicesOuvrir le communiqué original →