Title

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

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