FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies

PetImage via Pixabay

WASHINGTON, D.C. — Veterinary regenerative medicine is a rapidly growing area of product development that offers great promise in the development of novel therapies for animals. These products, which include animal cell-based therapies such as stem cells, have the potential to repair diseased or damaged tissues in animals through regeneration and healing.

the U.S. Food and Drug Administration this week announced a listing of clinical field studies that are investigating Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs) in veterinary patients. The webpage provides animal owners, veterinarians, researchers and the public with information on clinical field studies that are being investigated for the use of ACTPs in veterinary patients.

The FDA is offering this webpage as a resource because we’ve heard from veterinarians and pet owners who are eager to take part in clinical studies and avail their patients and pets of the potential that veterinary regenerative medicine may offer. Connecting interested pet owners and their veterinary teams with relevant clinical studies also helps sponsors in generating data toward potential FDA approval.

READ:  Department of Agriculture Answers Frequently Ask Questions About Dog Wardens Role, Animal Cruelty

Generally, the FDA regulates ACTPs as animal drugs if they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (e.g., osteoarthritis and tendon injuries in animals) in animals, or intended to affect the structure or any function of the body (e.g., improving animal fertility) of animals. The FDA’s Center for Veterinary Medicine provides regulatory oversight of clinical field studies for ACTPs, provides veterinary medical researchers with information to address scientific challenges and provides guidance on the regulatory process for their products. FDA also offers the Veterinary Innovation Program (VIP) to certain sponsors of ACTPs, which helps facilitate advancements in the development of innovative animal products by encouraging development and research, and supporting an efficient and predictable pathway to approval for these products.

Clinical field study information on the webpage includes study name, species, condition, product type, recruitment period, study period, country or state and phone number and/or email address of the sponsor. Clinical field studies evaluating ACTPs are listed on the webpage when the sponsor has provided specific information to the FDA about the study and the sponsor consents to having their study information listed on the webpage. At the time of listing, the information is intended to disclose clinical field studies in support of product development and FDA approval.

READ:  Court Upholds FTC’s Opinion Against Generic Pharmaceutical Company Impax Laboratories, LLC

Participation is voluntary in clinical field studies for investigational ACTPs, and sponsors must voluntarily consent to having the FDA list their study information on the webpage. The studies listed on the webpage are investigational, and the ACTPs are not FDA-approved. This means the safety and effectiveness of the ACTP is not yet determined. The webpage will be updated with new clinical studies on a quarterly basis, and FDA expects the list of studies to grow.

“We welcome the opportunity to continue working with ACTP sponsors to discuss innovative approaches in developing treatments needed to support safe and effective animal therapies. Our ultimate objective is to obtain interpretable data from well-conducted, well-designed scientific studies.,” stated Steven M. Solomon D.V.M., M.P.H., Director of the Center for Veterinary Medicine. “We look forward to working with individuals, universities and drug companies who develop this information and to gain a fuller understanding of the potential benefits and risks associated with ACTPs.”

READ:  Secretary of Agriculture Recognizes Benefits of Kennel Inspections for Quality Dog Breeders, Consumers

As scientists continue to research new and innovative therapies for animal health using animal cells and tissue, FDA encourages sponsors to develop the data needed to seek potential FDA-approval for their ACTPs. At the same time, FDA stated they remain committed to taking action as necessary to protect public health against companies that illegally market ACTPs.

Sponsors of ACTPs that are interested in having their clinical trials listed on the FDA’s webpage can contact their FDA project manager.

Thanks for visiting! MyChesCo brings reliable information and resources to Chester County, Pennsylvania. Please consider supporting us in our efforts. Your generous donation will help us continue this work and keep it free of charge. Show your support today by clicking here and becoming a patron.

Buy Us a Cup of Coffee