View Rule

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