South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What does INDA stand for?

1. Investigational New Drug Application

2. Individual New Drug Approval

3. Initial New Drug Assessment

4. Interim New Drug Agreement

The correct answer is: Investigational New Drug Application

The term INDA stands for Investigational New Drug Application. This is a submission made to the Food and Drug Administration (FDA) in the United States by a pharmaceutical company seeking permission to begin clinical trials on a new drug. The INDA provides the FDA with data from laboratory and animal studies that suggest the drug may be safe for human use, as well as details about the drug's composition, manufacturing process, and the planned clinical study protocols. The primary goal of the INDA is to ensure that the clinical trials can be conducted safely and ethically while providing necessary information on how the drug will be used in humans. Understanding the INDA is crucial for anyone involved in pharmaceutical research and development, as it marks the transition from preclinical to clinical phases in drug development, ensuring that the FDA is informed and can oversee the testing of potentially new therapeutic agents.