Entreprise · 15/09/20171 min de lecture
The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Draft Guidance for Industry; Availability
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Résumé
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GIF) #210 entitled "The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." This draft guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).