What is the purpose of 21 CFR 312?

The purpose of 21 CFR 312 is to provide regulations pertaining to the application for an Investigational New Drug (IND). This specific regulation outlines the procedures and requirements that sponsors must follow when seeking approval to begin clinical trials of new drugs. The primary goal of 21 CFR 312 is to ensure that any drug intended for human use undergoes proper testing in a controlled environment to assess its safety and efficacy before it can be marketed to the public.

The regulation sets forth the necessary information that must be included in an IND application, such as study protocols, preclinical data, and manufacturing information. This framework is critical in protecting the health and safety of research subjects and the public, as it establishes standards for how drugs are developed and tested.

While guidelines for post-marketing surveillance, regulations for drug advertising, and criteria for drug importation are all important aspects of the regulatory landscape, they are governed by different sections of the Code of Federal Regulations. Thus, they do not fall under the specific purview of 21 CFR 312, which focuses exclusively on the process of starting clinical trials for new drug applications.