South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What documents must be submitted prior to human testing of a new drug?

1. New Drug Application (NDA)

2. Investigational New Drug Application (INDA)

3. Patient consent forms

4. Clinical trial reports

The correct answer is: Investigational New Drug Application (INDA)

The correct response is related to the Investigational New Drug Application (INDA). Before a new drug can undergo human testing, the sponsor must submit an INDA to the FDA. This document includes essential information about the drug, including results from preclinical studies, the proposed plan for the clinical trials, and information about how the drug will be manufactured and tested. This application is crucial for ensuring that the proposed trials are safe and ethical, as it allows the FDA to assess the drug's safety in human subjects prior to initiating widespread clinical testing. In contrast, a New Drug Application (NDA) is submitted after the clinical trials have been completed, supporting the request for marketing approval of the drug. Patient consent forms are indeed necessary during the human testing phase to ensure that participants are informed about the study and agree to participate, but these forms are not submitted to the FDA prior to starting human trials. Clinical trial reports are generated after trials are completed and are part of the data submitted in the NDA to demonstrate the drug's efficacy and safety.