The contractor shall properly store, adequately test, and evaluate shelf life samples of investigational clinical drug formulations, including both injectable products and oral dosage forms, and report the results of such testing to the Pharmaceutical Resources Branch. These reports will be used for providing NCI and its investigators with information regarding the proper storage and handling of various drug products under investigation, for determining appropriate expiration dates for the products, and to support NCI's Investigational New Drug Applications (INDs) files with the Food and Drug Administration (FDA). In addition, the project will require storage and inspection of reserve samples as defined by the FDA Current Good Manufacturing Practices regulations (CGMPs).
