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Guidance on Distributor Labeling for Animal Drugs


Federal Register Notice: FDA is making available a draft guidance for industry entitled Distributor Labeling for New Animal Drugs. It discusses the agency’s current thinking on 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 in ways other than those permitted by regulation. To download this guidance, click here. To view this notice, click here.