title: What's the Regulatory Value of a Target Product Profile?
abstract: Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog.
authors.affiliation: Johns Hopkins University, Krieger School of Arts and Sciences, Advanced Academic Programs, Master of Science in Regulatory Science Program, Baltimore, MD, USA; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Drug Evaluation 1, Division of Neurology Products, Silver Spring, MD, USA. Electronic address: cbreder1@jhu.edu.
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Breder
authors.affiliation: Johns Hopkins University, Krieger School of Arts and Sciences, Advanced Academic Programs, Master of Science in Regulatory Science Program, Baltimore, MD, USA; Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA.
authors.forename: Wenny
authors.initials: W
authors.lastname: Du
authors.affiliation: Johns Hopkins University, Krieger School of Arts and Sciences, Advanced Academic Programs, Master of Science in Regulatory Science Program, Baltimore, MD, USA; Catalent Pharma Solutions, LLC, Woodstock, IL, USA.
authors.forename: Adria
authors.initials: A
authors.lastname: Tyndall
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
keywords: product development; target product profile; time to market