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  4. For Sponsors: CVM Listing of Clinical Field Studies for Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)
  1. Development & Approval Process

For Sponsors: CVM Listing of Clinical Field Studies for Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)

Why should I list my clinical field study on this webpage?

Listing your study on this webpage helps to provide transparency on research and development of these novel products. Providing this study information may:

  • Assist animal owners and veterinarians with accessing available clinical field studies
  • Aid study enrollment
  • Help animals to gain access to potentially beneficial treatments
  • Publicly demonstrate efforts to develop novel products for animal use
  • Serve as a reference for owners of potential enrollees to determine the legitimacy of a study

When does CVM list a clinical field study on this webpage? 

Clinical field studies evaluating ACTPs are listed on the “Clinical Field Studies for ACTPs” webpage when:

  • The study is conducted under an open file (e.g., Investigational New Animal Drug (INAD) file) with CVM; and 
  • The file contains information on the study design, objective, evaluations, subjects and other information to support that the study is a bonified scientific study appropriate for the product’s development; and
  • The sponsor consents to having their study information listed on the webpage; and
  • At the time of the sponsor’s request, CVM determines that the study information is eligible to post (e.g., the file is up-to-date and in compliance with regulatory requirements).

Does listing my study information on this webpage allow me to promote or advertise my product?

No.  Because your ACTP is investigational, you cannot commercially distribute nor test-market your ACTP until a new animal drug application is approved pursuant to section 512(c) of the Food, Drug, and Cosmetic Act.  See 21 CFR § 511.1(b)(8)(v).

Must I provide consent to have my study information listed on this webpage?

Yes. If you do not provide consent, we will not list your study information. Your consent will be documented in your file’s administrative record.

What study information will CVM list on this webpage?

CVM only lists the following information related to a clinical field study on the “Clinical Field Studies for ACTPs” webpage:

  • Study name
  • Species
  • Condition
  • Product type
  • Recruitment period
  • Study period
  • Country or State
  • Phone number and/or email address.

As a sponsor, how do I get started?

Sponsors interested in requesting that their study information be included in CVM’s listing on the “Clinical Field Studies for ACTPs” webpage can reach out to their CVM Project Manager for more information.

Contacting CVM at least three months prior to the start of study enrollment will assist CVM in listing your study information in a timely fashion.

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