BUDGET;
DRUG APPROVAL;
DRUG EFFICACY;
DRUG INDUSTRY;
DRUG RESEARCH;
DRUG SAFETY;
FEE;
FOOD AND DRUG ADMINISTRATION;
FUNDING;
LAW;
NOTE;
ORGANIZATION;
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
RESPONSIBILITY;
UNITED STATES;
USER FEE;
ARTICLE;
DRUG LEGISLATION;
ECONOMICS;
FINANCIAL MANAGEMENT;
HEALTH CARE POLICY;
LEGAL ASPECT;
MANAGEMENT;
ORGANIZATION AND MANAGEMENT;
POLITICS;
STANDARD;
BUDGETS;
DRUG APPROVAL;
DRUG INDUSTRY;
FINANCING, GOVERNMENT;
HEALTH POLICY;
LEGISLATION, DRUG;
MANAGEMENT AUDIT;
POLITICS;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Omnibus Appropriations Act 2009. Pub L No. 111-8, 123 Stat 524, 551-552, Division A, Title VI (March 11, 2009).
Omnibus Appropriations Act 2009. Pub L No. 111-8, 123 Stat 524, 551-552, Division A, Title VI (March 11, 2009).
2
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and, budget, Accessed June 11, 2009
US Food and Drug Administration. Summary of the FDA's FY 2010 budget. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/ucm153154. htm. Accessed June 11, 2009.
Prescription Drug User Fee Amendments of 2007 (PDUFA IV). 21 USC §379g-379h (Supp 2009).
Prescription Drug User Fee Amendments of 2007 (PDUFA IV). 21 USC §379g-379h (Supp 2009).
4
67650667369
US Food and Drug Administration. PDUFA reauthorization performance goals and procedures: fiscal years 2008 through 2012. http://www.fda.gov/ForIndustry/ UserFees/PrescriptionDrugUserFee/ucm119243.htm. Accessed June 11, 2009.
US Food and Drug Administration. PDUFA reauthorization performance goals and procedures: fiscal years 2008 through 2012. http://www.fda.gov/ForIndustry/ UserFees/PrescriptionDrugUserFee/ucm119243.htm. Accessed June 11, 2009.
5
67650660572
Food and Drug Administration Amendments Act. Pub L No. 110-85, 121 Stat 823, 825, Title I, §101(c) (September 27, 2007).
Food and Drug Administration Amendments Act. Pub L No. 110-85, 121 Stat 823, 825, Title I, §101(c) (September 27, 2007).
6
67650667367
Prescription drug user fee rates for FY 2009
and Drug Administration
US Food and Drug Administration. Prescription drug user fee rates for FY 2009. Fed Regist. 2008;73(149):45017-45022.
(2008)Fed Regist, vol.73, Issue.149, pp. 45017-45022
Prescription Drug User Fee Amendments of 2007 (PDUFA IV). 21 USC §379h-2 (Supp 2009).
Prescription Drug User Fee Amendments of 2007 (PDUFA IV). 21 USC §379h-2 (Supp 2009).
8
67650684887
Letter from Michael O. Leavitt to Rep John Dingell. September 27, 2007. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/ UCM119239.pdf. Accessed June 11, 2009.
Letter from Michael O. Leavitt to Rep John Dingell. September 27, 2007. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/ UCM119239.pdf. Accessed June 11, 2009.
9
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US Food and Drug Administration. Applications for FDA approval to market a new drug. 21 CFR §314.101(a)(1) (2008).
US Food and Drug Administration. Applications for FDA approval to market a new drug. 21 CFR §314.101(a)(1) (2008).
10
41449104685
Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems [published correction appears in N Engl J Med. 2008;359(1):95-98]. N Engl J Med. 2008;358(13):1354-1361.
Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems [published correction appears in N Engl J Med. 2008;359(1):95-98]. N Engl J Med. 2008;358(13):1354-1361.
11
34248400810
and, April 2005, Accessed June 11, 2009
US Food and Drug Administration. Guidance for review staff and industry: good review management principles and practices for PDUFA products. April 2005. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM079748.pdf. Accessed June 11, 2009.
Food Drug and Cosmetic Act, as amended by §119(a) of FDA Modernization Act of 1997. 21 USC §355(b)(5)(C)(ii) (1999).
Food Drug and Cosmetic Act, as amended by §119(a) of FDA Modernization Act of 1997. 21 USC §355(b)(5)(C)(ii) (1999).
13
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Accessed June 11, 2009
PDUFA IV performance goal VI (A)(5): special protocol question assessment and agreement. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ ucm119243.htm. Accessed June 11, 2009.
