The FDA reviews applications to market drug products to determine whether those drug products are safe and effective for their intended indications. The FDA reviews scientific investigations, including adequate and well-controlled clinical trials, as part of the FDA’s drug approval process.
The FDA relies on applicants and scientific investigators to conduct research. Our role, as outlined in the Federal Food, Drug, and Cosmetic Act, is to review data submitted to the FDA in a marketing application to determine whether a proposed drug product meets the statutory standards for approval. Additional information concerning research on the medical use of marijuana is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and NIDA.