Regulatory Affairs Certification (RAC) Practice Exam

Which statement is NOT true regarding IND Applications and IDEs for significant-risk products?

1. The investigational product must be manufactured in full compliance with CGMP

2. Clinical studies must be reviewed and approved by an IRB

3. The IND or IDE goes into effect 30 days after submission if no response is received from FDA

4. The application must include an environmental risk assessment or a categorical exclusion

The correct answer is: The investigational product must be manufactured in full compliance with CGMP

The statement that the investigational product must be manufactured in full compliance with CGMP is not true with respect to IND Applications and IDEs for significant-risk products. While current good manufacturing practices (CGMP) are essential for the production of materials for clinical trials, there is a distinction in regulations regarding investigational products. For investigational new drug (IND) applications, the FDA does require compliance with CGMP standards once the product is in clinical trials. However, during the early stages of development and prior to the clinical phase, full compliance may not be mandatory for the investigational product used in studies, as it is still undergoing evaluation and not yet approved for general use. In contrast, the other statements reflect true aspects of the regulatory process for IND Applications and IDEs. Clinical studies must indeed undergo review and approval by an Institutional Review Board (IRB), which serves to protect the rights and welfare of human subjects involved in research. The IND or IDE process is designed such that if the FDA does not respond within 30 days of submission, the application automatically goes into effect, allowing the sponsor to proceed with the study. Additionally, an environmental risk assessment is often required to evaluate the potential effects of the investigational product on the environment or to provide just