title: Communicating with the FDA: the "third rail" of a new model for drug development.
authors.affiliation: Global Head Modeling and Simulation, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080, USA. donald.stanski@novartis.com
authors.forename: Donald R
authors.initials: DR
authors.lastname: Stanski
authors.forename: John J
authors.initials: JJ
authors.lastname: Orloff
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods / Q000706:statistics & numerical data; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D033183:Interdisciplinary Communication; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence / Q000379:methods / Q000706:statistics & numerical data; D007880:Legislation, Drug / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000458:organization & administration / Q000592:standards