Understanding the Regulatory Pathways Used to Develop, Evaluate, Authorize, and Approve New Drugs and Vaccines in the United States.
J Pediatric Infect Dis Soc
; 13(Supplement_2): S93-S102, 2024 Jul 12.
Article
in En
| MEDLINE
| ID: mdl-38995086
ABSTRACT
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
United States Food and Drug Administration
/
Vaccines
/
Drug Approval
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
J Pediatric Infect Dis Soc
Year:
2024
Document type:
Article
Affiliation country:
United States