title: Regulatory watch: impact of PDUFA on regulatory decision-making.
authors.forename: Michael
authors.initials: M
authors.lastname: Hay
mesh_terms: D003659:Decision Making, Organizational; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence*; D005249:Fees and Charges / Q000331:legislation & jurisprudence; D006801:Humans; D007880:Legislation, Drug; D012308:Risk Management / Q000191:economics; D014481:United States; D014486:United States Food and Drug Administration