Distributor Labeling for New Animal Drugs; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GIF) #231 entitled ``Distributor Labeling for New Animal Drugs.'' This draft guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a New Animal Drug Application or Abbreviated New Animal Drug Application (NADA/ANADA) in ways other than those permitted by regulation.