• Investigational New Drug (IND) — Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines.
• New Drug Application (NDA) — When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet FDA’s requirements for marketing approval, the sponsor submits a new drug application (NDA) to FDA. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States.
• Abbreviated New Drug Application (ANDA) – An Abbreviated New Drug Application contains data that provides for the review and ultimate approval of a generic drug product. Generic drug applications are called “”abbreviated”” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic drug applicant must scientifically demonstrate that its product is bioequivalent (performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product.
• Biologic License Application (BLA) — Biological products are approved for marketing under the provisions of the Public Health Service Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.
