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# Guidance on Animal Drug Comparability Protocols
- URL: https://www.fdaweb.com/guidance-on-animal-drug-comparability-protocols/
- Published: 2016-04-04T12:00:00.000Z
- Updated: 2026-09-14T20:52:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135265

*Federal Register* Notice: FDA is making available a final guidance entitled *Comparability Protocols —Chemistry, Manufacturing, and Controls Information for New Animal Drugs*. This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations to industry on comparability protocols that would be submitted in NADAs, ANADAs, or supplements to these applications. This guidance also applies to comparability protocols submitted in investigational new animal drug, generic investigational new animal drug, and veterinary master file submissions that are referenced in applications. To download this guidance, click here. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07573.pdf?ref=fdaweb.com)