West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

When is a New Drug Application (NDA) or Biologics License Application (BLA) submitted to the FDA?

1. After successful Phase I trials

2. After successful Phase II trials

3. After successful Phase III trials

4. Before any clinical trials

The correct answer is: After successful Phase III trials

A New Drug Application (NDA) or Biologics License Application (BLA) is submitted to the FDA after successful Phase III trials. This phase is critical as it involves a larger population and aims to determine the drug's effectiveness, benefits, and the range of possible adverse reactions in a more diverse patient group. By the time a sponsor reaches Phase III, they have already gathered considerable data from the earlier phases—Phase I focusing on safety and dosage, and Phase II focusing on efficacy and side effects. The culmination of these trials provides the comprehensive data needed to support the efficacy and safety of the product for the intended use when the NDA or BLA is submitted. The submission itself is a formal request for the FDA to approve the new drug or biologic for market entry based on the results from these clinical trials. The FDA thoroughly reviews this application to ensure that the product meets the necessary standards for safety and effectiveness before it can be made available to the public.