title: An overview of drug development in the United States and current challenges.
abstract: Drug development in the United States has undergone many changes in the past 25 years, but relatively few fully realize the complexities involved in developing a new drug. Once a promising compound is identified, it must undergo preclinical testing, have an Investigational New Drug Application filed with the U.S. Food and Drug Administration (FDA), and proceed through clinical testing. When sufficient information is gained, a marketing application is filed with the FDA, who identifies it as a New Drug Application for drugs or a Biologics License Application for biologics. After FDA review and approval, postmarketing studies are frequently performed. The FDA and Congress have undertaken several initiatives to expand access and to accelerate drug development and review of investigational drugs for life-threatening and/or serious illnesses. Although the ultimate goal is to bring safer and more effective medical products to patients in a timely manner, multiple challenges face those who participate in drug development.
authors.affiliation: Medical and Regulatory Affairs, Clinical Trial Management Services, Inc., Bristol, TN 37620, USA. smoore@ctmsinc.com
authors.forename: Sharon Wyatt
authors.initials: SW
authors.lastname: Moore
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods; D018795:Device Approval; D017277:Drug Approval / Q000458:organization & administration*; D004353:Drug Evaluation, Preclinical / Q000379:methods; D028744:Ethics Committees, Research / Q000458:organization & administration; D006801:Humans; D009965:Orphan Drug Production; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*