Research Topics
| Daniel CarpenterSummaryAffiliation: Harvard University Country: USA Publications
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Publications
Drug-review deadlines and safety problemsDaniel Carpenter
Department of Government, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138, USA
N Engl J Med 358:1354-61. 2008..Critics have suggested that these deadlines may result in rushed approvals and the emergence of unanticipated safety problems once a product is in clinical use...
Approval times for new drugs: does the source of funding for FDA staff matter?Daniel Carpenter
Department of Government, Harvard University, Cambridge, Massachusetts, USA
Health Aff (Millwood) . 2003..NDA review times shortened by 3.3 months for every 100 additional FDA staff. The amount of funding for FDA staff appears to be a much more important influence on NDA review time than the source of funding...
A proposal for financing postmarketing drug safety studies by augmenting FDA user feesDaniel Carpenter
Department of Government, Harvard University, Cambridge, Massachusetts, USA
Health Aff (Millwood) . 2005..S. health care system; spread the burden of funding postmarketing safety studies among pharmaceutical sponsors; and help restore public, scientific, and professional confidence in the FDA and its user-fee system...
Forcing pharmaceutical history into boxesDaniel Carpenter
Harvard University, USA
J Health Polit Policy Law 31:1015-9. 2006
Staff resources speed FDA drug review: a critical analysis of the returns to resources in approval regulationDaniel Carpenter
Harvard University, USA
J Health Polit Policy Law 29:431-42; discussion 443-50. 2004
Essay: the political logic of regulatory errorDaniel Carpenter
Department of Government, 1737 Cambridge St, CGIS N405, Harvard University, Cambridge, Massachusetts 02138, USA
Nat Rev Drug Discov 4:819-23. 2005..Here, we provide a theoretical discussion of the factors that could influence regulatory error, drawing on the Vioxx episode in particular as a possible example of error, and consider the implications for future regulatory policy...
