Animal Health Institute filed 1 comment on this docket between Aug 8, 2024 and Aug 8, 2024. 1 other organizations filed here. The comment window closed 718d ago.
The ANIMAL HEALTH INSTITUTE (AHI) appreciates the opportunity to comment on the proposed rule, "Labeling Requirements for Approved or Conditionally Approved New Animal Drugs." Explanation on FDA CVM's current thinking on the expectations for labeling of approved animal products has been greatly anticipated. Our comments are attached.
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.
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