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Regulatory Application Sponsor
Definition 1
The party who submits a marketing application to FDA for approval of a drug, device, or biologic product. An applicant is the person or entity who assumes responsibility for the marketing of a new medical product, 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. (NCI Thesaurus)
Definition 2
An organization or person that assumes responsibility for producing and submitting documentation to a regulatory authority to seek approval for testing, marketing and the continuation of marketing of new drugs or devices. EXAMPLE(S): pharmaceutical company. (NCI Thesaurus/BRIDG)
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