FDA Approval of Animal Drugs for Minor Uses and Minor Species; Draft Guidance Document; Availability; Request for Comments

摘要

The Food and Drug Administration (FDA) is announcing the availability for comment on a draft Level 1 guidance document entitled ``FDA Approval of Animal Drugs for Minor Uses and for Minor Species.'' The guidance document defines minor species and minor uses and sets forth suggestions for generating safety and effectiveness data to support the approval of minor use and minor species drugs. The draft Level 1 guidance document sets forth substantive changes in policy that warrant input from affected parties.