CVM GFI #152 Guidance on Antimicrobial New Animal Drugs

Key changes

Updated safety assessment standards for antimicrobial drugs; revised recommendations for evaluating antimicrobial resistance (AMR) risk; clarified data requirements for new animal drug applications regarding human health impact.

PV impact

Sponsors of antimicrobial animal drugs must incorporate these safety assessment standards into their product monitoring and risk management plans. The guidance emphasizes the need for ongoing surveillance of antimicrobial resistance, which is a critical safety consideration for this class of medicinal products in the context of one-health pharmacovigilance.

Exact policy details

Pre-approval safety evaluation

FDA must determine that the drug is safe and effective for its intended use in the animal.

Applies to: Antimicrobial new animal drugs intended for use in food-producing animals

Section 512(d)(1) of the Federal Food, Drug, and Cosmetic Act · p. 1 · High · Source

Human health safety determination

Reasonable certainty of no harm to human health from the proposed use of the drug in food-producing animals.

Applies to: Antimicrobial new animal drugs intended for food-producing animals

21 CFR 514.1(b)(8); sections 512(d)(1)(B) and 512(d)(2)(A) of the FD&C Act · p. 1 · High · Source

Risk assessment methodology

The guidance outlines a risk assessment approach to evaluate the microbial food safety risks posed by antimicrobial new animal drugs.

Applies to: Sponsors of the new animal drug applications

Introduction Section · p. 3 · High · Source

Consultation with FDA

Sponsors are encouraged to consult with FDA to decide if the risk assessment approach is suitable for NADAs.

Applies to: NADAs for antimicrobial drug combinations and supplemental NADAs

Scope of Guidance Document Section · p. 4 · High · Source

Workflow rule impacts

Extracted documents

• CVM Guidance for Industry #152htmlhtml · high · 1 page
• Download the Final Guidance Documentpdfpdf_text · high · 37 pages
• Search for FDA Guidance Documentshtmlhtml · high · 1 page
• Advisory Committee Guidance Documentshtmlhtml · high · 1 page