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GUIDANCE DOCUMENT

CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis December 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-1993-D-0285

Docket Number:
FDA-1993-D-0285
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance provides target animal safety and effectiveness study design considerations and recommendations for sponsors of bovine mastitis drug products with antibacterial activity that are administered by intramammary infusion.  This guidance replaces the original guidance for industry (GFI) #49, issued in April 1996, entitled “Target Animal Safety and Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products).”  Sponsors may propose alternatives, with appropriate justification, to the study designs described in this guidance.  CVM encourages sponsors to meet with us early in their investigational product development timeline to propose and agree on the appropriate study designs for their specific project. 

 

Questions?

Contact Point
Paulette Salmon
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-133
Rockville, MD 20855
pauline.salmon@fda.hhs.gov
240-402-6556
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