Preferred Label : Regulatory Application Sponsor;

NCIt synonyms : Drug Sponsor; Application Sponsor; Applicant;

NCIt related terms : RegulatoryApplicationSponsor;

NCIt definition : 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.;

Alternative definition : BRIDG 3.0.3: 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.; BRIDG 5.3: 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 OTHER NAME(S): NOTE(S):;

Details


Main resources

You can consult :


https://www.societe-francaise-neonatalogie.com/_files/ugd/d8ff38_6ad94734aac6452b809fab8a09d77c1c.pdf
2023
France
scientific and technical information
infant, newborn
Safety
New Lesion Identification
neonatal nursing
Quality of Care
critical care
Applicant
Going Well
Safety Study
safety
quality of health care
Regulatory Application Sponsor
Newar Language
newborn, nos
nursing
NES Gene

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11/05/2024


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