What are the definitions for the Milestones terminology in Investigator Portal?
Abbreviated New Drug Application (ANDA): (Only applicable for the U.S. Food and Drug Administration). Contains data that, when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs (ANDA Filed), 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 applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved (ANDA Approved), an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative. Acquired: A product is acquired by a new company, usually by acquisition/merger with another company. Application withdrawn: An application for approval (NDA filed, sNDA filed, BLA filed, sBLA filed, ANDA filed i
