Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Industry; Availability

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry (GFI) #299 entitled "Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication." This guidance is intended to inform new animal drug sponsors that dual labeling of a new animal drug product may include an intended use that is fully approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and an intended use that is conditionally approved under section 571 of the FD&C Act where the claim to be added to the existing product labeling is intended to treat or prevent New World screwworm myiasis.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.