title: Food and Drug Administration Drug Approval Process: A History and Overview.
abstract: In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively.
authors.affiliation: DNP Program, Vanderbilt University School of Nursing, 461 21st Avenue South, Nashville, TN 37240, USA. Electronic address: christopher.t.williams@vanderbilt.edu.
authors.forename: Christopher Ty
authors.initials: CT
authors.lastname: Williams
mesh_terms: D017277:Drug Approval / Q000191:economics / Q000266:history* / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational / Q000191:economics / Q000266:history*; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history*; D019155:Veterinary Drugs / Q000191:economics / Q000266:history*
chemical_list: D015507:Drugs, Investigational; D019155:Veterinary Drugs
keywords: Drug approval; Drug review; Expedited reviews; Food and Drug Administration