USA/2105
WTO/TBT
US Vereinigte Staaten von Amerika
  • 11 - Medizintechnik
2024-06-10
2024-03-15

New animal drugs labeling; Veterinary medicine (ICS code(s): 11.220)

Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; (76 page(s), in English)

Proposed rule - The Food and Drug Administration (FDA) is proposing to revise the requirements for the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR). As part of this revision, certain current requirements would be updated and moved, and certain obsolete requirements would be removed. The proposed requirements would apply to the labeling of prescription and over-the-counter (OTC) new animal drugs, as well as new animal drugs for use in animal feeds.