View Rule

FDA is issuing procedural regulations for conditional approval of new animal drugs for minor use and minor species under the conditional approval provisions of the Federal Food, Drug, and Cosmetic Act. The new regulations are intended to make more medications for minor use and minor species legally available to veterinarians and animal owners. Conditional approval allows the sponsor to market the drug after demonstrating the drug is safe in accordance with the full FDA approval standard and showing that there is a reasonable expectation of effectiveness but before collecting all necessary effectiveness data for full approval. The drug sponsor can keep the product on the market for up to 5 years, through annual renewals, while collecting all necessary effectiveness data required for full approval.