FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DUAL LABELING FOR FULLY APPROVED AND CONDITIONALLY APPROVED NEW ANIMAL DRUGS WITH A NEW WORLD SCREWWORM-RELATED INDICATION; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Oct. 16 -- Food and Drug Administration has issued a notice called: Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Industry; Availability.

The notice was published in the Federal Register on Oct. 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 labelin...