THOUGHT LEADERSHIP

At PROMETRIKA, we provide biostatistical analysis and regulatory medical writing services to our sponsor companies who have reached the stage of New Drug Application (NDA) or Biologic Licensing Application (BLA) preparation. One of the many crucial documents in these applications is the Package Insert (a.k.a., Prescribing Information or Product Information; PI), the summary of safety and efficacy data on proposed new drugs and biopharmaceuticals (‘drug’ will be used to refer to both hereafter). In the following discussion, I will trace the source and distillation of the efficacy data presented in the PI.