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GUIDANCE DOCUMENT

CVM GFI #281 Infectious Otitis Externa Drugs for Topical Use in Dogs March 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-0606
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The effectiveness development plan for topical otic products should be designed to show that the drug product is effective for its intended use (i.e., to treat otitis externa) and, if it is a combination product, each active ingredient makes a contribution to the effectiveness of the combination.

Target animal safety (TAS) studies aim to identify the margin of safety and provide veterinarians with information regarding the safe use of the drug.   This guidance includes recommendations specific for topical otic drug products.  Human user safety covers human exposures resulting from actual conditions of use and is part of the TAS technical section.  Human user safety concerns for topical otic drug products should be addressed, including potential exposure to the drug and the active metabolites by veterinary personnel, people handling the drug, and people in contact with the animal.

The pathogenic species listed on the package insert will be determined by the results of the field effectiveness study that support substantial evidence of effectiveness.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-0606.

Questions?

Contact Point
Lea Cranford
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-118
Rockville, MD 20855
lea.cranford@fda.hhs.gov
240-402-0615
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