What is the focus of 21 CFR - Part 312.33?

The focus of 21 CFR - Part 312.33 is on the requirements for investigational new drug applications (IND). This regulation outlines the necessary information that must be submitted to the Food and Drug Administration (FDA) by sponsors or investigators when they wish to test a new drug in humans. The purpose of this part is to ensure that any investigational new drug is safe for use and that the data collected during the trials will be reliable and substantive.

By detailing the required data submission protocols, including preclinical study results, information about the drug’s composition, and proposed clinical trial protocols, 21 CFR - Part 312.33 aims to facilitate a comprehensive review process by the FDA before any clinical testing can begin. This ensures that potential risks are evaluated and managed effectively while also promoting the protection of participants involved in the clinical trials.

Understanding this regulation is crucial for any professional involved in the clinical research process, as it lays the foundational requirements for conducting ethical and scientifically sound clinical investigations.