Understanding the Regulatory Pathways Used to Develop, Evaluate, Authorize, and Approve New Drugs and Vaccines in the United States.

Publisher: Oxford University Press Country of Publication: England NLM ID: 101586049 Publication Model: Print Cited Medium: Internet ISSN: 2048-7207 (Electronic) Linking ISSN: 20487193 NLM ISO Abbreviation: J Pediatric Infect Dis Soc Subsets: MEDLINE

Original Publication: Oxford : Oxford University Press

United States Food and Drug Administration* ; Drug Approval*/legislation & jurisprudence ; Vaccines*/therapeutic use; United States ; Humans ; Drug Development/legislation & jurisprudence ; United States Dept. of Health and Human Services

The United States (U.S.) Food and Drug Administration (FDA) oversees the safety and quality of drugs and vaccines that are used in the U.S. Administration of the FDA falls under the jurisdiction of the U.S. Department of Health and Human Services (HHS). The regulatory oversight of the FDA is complex and comprehensive, requiring the various roles and responsibilities to be divided across six main centers. The activities of two of these centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the primary focus of this review.
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Keywords: CBER; CDER; FDA approval process; phases of clinical trials; vaccine development

0 (Vaccines)

Date Created: 20240712 Date Completed: 20240712 Latest Revision: 20240716

20240716

10.1093/jpids/piae036

38995086