HOW NRSP-7 WORKS
Research for the Minor Use Animal Drug Program is funded through a USDA special research grant and administered by NRSP-7. NRSP-7 also receives support from pharmaceutical firms, universities, and State Agricultural Experiment Stations. Research projects are initiated by requests (usually from researchers or animal producers) to the program’s regional coordinators to address a particular minor use drug need. These requests, known as ADS’s (Animal Drug Request), are prioritized according to financial and regulatory feasibility, importance to the animal industry, and the pharmaceutical manufacturer’s commitment to the minor use drug approval. Once a request is accepted as a research project, study protocols are developed. Research is conducted in accordance with FDA’s Good Laboratory Practices regulations. A successful research project is submitted to FDA’s Center for Veterinary Medicine as a public master file, and the availability of the data in the public master files is published in the Federal Register. A pharmaceutical sponsor may then reference, at no cost, the data in the public master files to support a new animal drug application for the minor use. The final step in the process is FDA approval of this application from the pharmaceutical sponsor, so that the product may be labeled and sold for the minor use. |