Your NDA Preparation Should Have Started by Now: Planning and Managing Your NDA Submission
Throughout our years of preparing and filing Food and Drug Administration (FDA) submissions, Premier Consulting has often encountered sponsors who cannot file a New Drug Application (NDA) or Biologic License Application (BLA) within expected time-frames, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date. In this document, we will highlight those requirements that seem to be the most misunderstood.