Indo Global Exchanges Pte Ltd (IGEX)

[Newdie999]

A Brief Summary of the Drug Approval Process:

FFDCA – Federal Food, Drug, and Cosmetic Act
FDA – Food and Drug Administration
CVM – Center for Veterinary Medicine
ONADE – Office of New Animal Drug Evaluation
OMUMS – Office of Minor Use and Minor Species Animal Drug Development
NADA – New Animal Drug Application

The drug sponsor collects information about the safety and effectiveness of a new animal drug. The sponsor may need to conduct studies to get this information. For any studies that are performed, the sponsor analyzes the results.

Based on the collected information, including any study results, the sponsor decides if there is enough proof that the drug is safe and effective to meet the requirements for approval.

The sponsor submits a New Animal Drug Application (NADA) to CVM. The NADA includes all the information about the drug and the proposed label.

A team of CVM personnel, including veterinarians, animal scientists, biostatisticians, chemists, microbiologists, pharmacologists, and toxicologists, reviews the NADA. If the center's team agrees with the sponsor’s conclusion that the drug is safe and effective if it is used according to the proposed label, CVM approves the NADA and the drug sponsor can legally sell the drug.

https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process#first