title: Regulatory watch: The target product profile as a tool for regulatory communication: advantageous but underused.
authors.affiliation: Catalent Pharma Solutions, 2210 Lakeshore Drive, Woodstock, Illinois 60098, USA.|JHUAAP and contributed equally to this project.
authors.forename: Adria
authors.initials: A
authors.lastname: Tyndall
authors.affiliation: Bayer, 100 Bayer Boulevard, Whippany, New Jersey 07981, USA.|JHUAAP and contributed equally to this project.
authors.forename: Wenny
authors.initials: W
authors.lastname: Du
authors.affiliation: Johns Hopkins University, Advanced Academic Programs in Regulatory Science (JHUAAP), 9601 Medical Center Drive, Rockville, Maryland 20850, USA. He is also a medical officer at the US Food and Drug Administration.
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Breder
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D033183:Interdisciplinary Communication; D014481:United States; D014486:United States Food and Drug Administration