Understanding Drug Development: A Primer on the Food and Drug Administration.
Document Type
Article
Publication Date
11-11-2021
Identifier
DOI: 10.1093/jpids/piab023; PMCID: PMC8344772
Abstract
Over the past year, the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic has led to rapid advancement regarding therapeutics, vaccines, and testing. In the United States, the Food and Drug Administration (FDA) is the agency ensuring standardization, reproducibility, and meeting benchmarks of safety and efficacy for these products. Among medical professionals and the public, there are often questions about the role of regulation, product development and approval, and terminology often used in regard to the FDA. This manuscript will serve as an introduction to the FDA, clarify the steps of drug development and approval, review terms related to product use, and discuss the role of the medical community and industry. The FDA serves as a regulatory agency ensuring safety, efficacy, and quality are met in the approval of drugs, vaccines, biologics, and testing products. Understanding the terms of development can help providers with many new products being developed.
Journal Title
J Pediatric Infect Dis Soc
Volume
10
Issue
10
First Page
977
Last Page
981
MeSH Keywords
COVID-19; Drug Approval; Humans; Pharmaceutical Preparations; Reproducibility of Results; SARS-CoV-2; United States; United States Food and Drug Administration
Keywords
EUA; FDA; drug development; regulation
Recommended Citation
Purandare AV. Understanding Drug Development: A Primer on the Food and Drug Administration. J Pediatric Infect Dis Soc. 2021;10(10):977-981. doi:10.1093/jpids/piab023Purandare AV. Understanding Drug Development: A Primer on the Food and Drug Administration. J Pediatric Infect Dis Soc. 2021;10(10):977-981. doi:10.1093/jpids/piab023
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