PDUFA reauthorization--drug safety's golden moment of opportunity?
Hennessy
Sean
S
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, USA.
Strom
Brian L
BL
D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000191:economics* / Q000331:legislation & jurisprudence; D005249:Fees and Charges; D033161:Government Regulation; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000191:economics*; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics / Q000331:legislation & jurisprudence* / Q000458:organization & administration