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GUIDANCE DOCUMENT

CVM GFI #215 Target Animal Safety & Effectiveness Protocol Development & Submission September 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0023
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

To facilitate the drug development process, the Center for Veterinary Medicine (CVM) recommends that sponsors submit protocols to CVM’s Office of New Animal Drug Evaluation’s (ONADE) Division of Therapeutic Drugs for Non-Food Animals, Division of Production Drugs, or Division of Therapeutic Drugs for Food Animals to review study designs before initiating a study to support substantial evidence of effectiveness or target animal safety. This guidance makes recommendations to aid in the preparation of protocols used to generate data to support new animal drug applications, specifically target animal safety and substantial evidence of effectiveness. The recommendations are intended to reduce the time to protocol concurrence by:

  • Recommending a path to protocol concurrence,
  • Enhancing quality of protocol submissions by focusing on agreements on study design and statistical analysis, and
  • Making use of opportunities to meet with CVM before and during protocol development.

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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-2011-D-0023.

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