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Update on Implementation of FDA’s Guidance for Industry #213
December 27, 2016 —
In preparation for implementing the changes outlined in Guidance for Industry #213 (GFI #213), the U.S. Food and Drug Administration issued three Federal Register documents to update the Code of Federal Regulations (CFR) reflecting changes being made to new animal drug applications affected by GFI #213. [Source: FDA CVM, December 23, 2016]
These documents, displaying today, are part of the required administrative procedures for approving new animal drug applications or processing requests to voluntarily withdraw new animal drug applications.
The changes reflected in these documents include the approval of changes to oral dosage form new animal drugs and new animal drugs for use in feeds, as well as the withdrawal of a number of new animal drug applications. Additional Federal Register documents are forthcoming to update the CFR to reflect the changes to new animal drug applications affected by GFI #213, but were not included in the documents displayed today.
The publication of these documents sets the stage for January 1, 2017, the date that FDA established for the changes outlined in GFI #213. FDA requested that all sponsors affected by GFI #213 work with the agency to complete the necessary changes to bring affected products into alignment by this date. These changes include removing growth promotion indications from the labels of their medically important antimicrobial products used in the feed or water of food-producing animals and bringing the remaining therapeutic uses under veterinary oversight.
The FDA will publish another CVM Update in early January summarizing actions related to GFI #213 and outlining the agency’s next steps.
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