FDA issues guidance on proprietary names for new animal drugsFDA issues guidance on proprietary names for new animal drugs
Draft guidance proposes framework for evaluating proposed proprietary names before submitting them for review by FDA’s Center for Veterinary Medicine.
March 9, 2018
The U.S. Food & Drug Administration issued draft guidance March 9 to provide recommendations to assist sponsors in developing proprietary names for new animal drugs in order to avoid contributing to medication errors, negatively affecting safe use of the drug or misbranding the drug.
Draft Guidance for Industry #240, titled "Proprietary Names for New Animal Drugs," proposes a framework for evaluating proposed proprietary names before submitting them for review by FDA’s Center for Veterinary Medicine. The draft guidance also explains how new animal drug sponsors can request agency evaluation of a proposed proprietary name, FDA said.
FDA evaluates proprietary names as part of the new animal drug approval process. Selecting a proprietary name is a critical element in the design and development of animal drug product labeling because end users (the prescribing veterinarian, veterinary technician, food animal producers, animal owners, pharmacist or pharmacy technician) may rely, in part, on the proprietary name to identify which product among the thousands of products available is intended for a given animal, the agency explained.
If end users cannot readily distinguish among proprietary names, the animal might receive an incorrect product, or it might be difficult to correctly identify the product used.
FDA also considers whether the proprietary name can contribute to medication errors. Examples of medication errors include incorrect drug selection, incorrect dosage or route of administration or use in unintended species or classes. These types of errors may cause animal injury or lead to a lack of drug effectiveness, which could contribute to outcomes like complication of a disease and possible death of the animal, FDA said.
FDA is accepting public comments beginning March 12. Comments should be submitted no later than May 11 for FDA to consider them in drafting the final guidance.
To electronically submit comments to the docket, visit www.regulations.gov, and type FDA-2018-D-0626 in the search box.
To submit comments to the docket by mail, be sure to include docket number FDA-2018-D-0626 on each page of the written comments, and send to the following address:
Dockets Management Staff, HFA-305, Food & Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
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