Success Factors for NDA/BLA Preparation

Abstract

The process by which the NDA/BLA is prepared, submitted, and supported throughout its evaluation is a key component of the timely approval and launch of a new drug or biologic product. Numerous important process issues and considerations must be addressed to maximize success, starting with early planning. Planning begins with a clear understanding of the goals and objectives of the project. An important next step is to form an appropriately qualified cross-functional team from which to obtain expert input (as well as management’s) on the plan. The plan should incorporate the appropriate research and development elements and follow the latest regulatory requirements and guidelines. It should be reviewed and updated periodically to reflect changes in the environment, both internal (i.e., chemistry, pre-clinical and clinical data) and external (e.g., competitive landscape, regulatory requirements, standards of clinical care, etc.)...