Description
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:
Scope & Applicability
Product Classes
1The category of products covered by this guidance.
Stakeholders
2Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
2Deadline established by CVM for submitting amendments
agreement between CVM and sponsor on study design
Related CFR Sections (1)
- 21CFR514.5§ 514.5 Presubmission conferences.
(a) General principle underlying the conduct of a presubmission conference. The general principle underlying the conduct of any presubmission conference is that there should be candid, full, and open communication.Read full regulation →