Applicant (Drug Sponsor)

An applicant, or drug sponsor, is the person or entity who assumes responsibility for the marketing of a new drug, including responsibility for compliance with applicable provisions of the Federal Food, Drug, and Cosmetic Act and related regulations. The "sponsor" is usually an individual, partnership, corporation, government agency, manufacturer or scientific institution.

For a list of addresses to send applications to, go to the Address page.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.