The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of guidance for industry #210 entitled "The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." This final 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 a certain section of the Federal Food, Drug, and Cosmetic Act (FD&C Act).