Detailed Explanation
The Investigational New Drug application represents the regulatory gateway to human clinical trials in the United States, providing the FDA with information necessary to evaluate whether proposed studies are reasonably safe for initial administration to humans. Before any clinical investigation of a new drug can begin, federal law requires that an IND be in effect, establishing a regulatory framework that protects trial participants while enabling the development of promising new therapies.
The IND submission must contain three principal categories of information. The Chemistry, Manufacturing, and Controls section describes the drug substance and drug product, including composition, manufacturing process, stability data, and quality controls. The Pharmacology and Toxicology section presents preclinical studies demonstrating that the drug is reasonably safe for initial human testing at the proposed doses. The Clinical section includes the protocol for initial human studies, qualifications of investigators, and the Investigator's Brochure summarizing all available information about the drug.