FDA review divisions: Performance levels and the impact on drug sponsors

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 3, 2012, Pages 393-404

  Milne, C P ^a   Kaitin, K I ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DATA ANALYSIS; DRUG APPROVAL; DRUG INDUSTRY; DRUG RESEARCH; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; PATIENT CARE; PRIORITY JOURNAL; REVIEW; SCORING SYSTEM; WORKLOAD;

ANIMALS; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG INDUSTRY; HEALTH PERSONNEL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; TASK PERFORMANCE AND ANALYSIS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857234569     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.338     Document Type: Review

References (16)

1. McCaughan, M. FDA and the R&D Crisis: Time to Stop the Blame Game, RPM Report, 6, 6-14 (2011) 〈http://www.elsevierbi.com/Publications/ RPMReport/7/7/FDA-and-the-RD-Crisis-Time-to-Stop-the-Blame-Game
2. Independent Evaluation of FDA's First Cycle Review Performance-Final Report, 16 July 2008, Booz, Allen & Hamilton, Contract No. 223-04-8100 Task No. 3 〈http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ ucm127117.htm
3. FDA's Review Process for New Drug Applications: A Management Review. Department of HealtHand Human Services, March 2003 〈http://oig.hhs.gov/oei/ reports/oei-01-01-00590.pdf
4. Rare Diseases and Orphan Products: Accelerating ResearcHand Development. Institute of Medicine Committee on Accelerating Rare Disease ResearcHand Orphan Product Development, 2010 〈http://www.ncbi.nlm.nih.gov/books/NBK56189/pdf/ TOC.pdf
5. Statement of Work for the Evaluation of First Cycle Review Performance (a letter from PhRMA), November 2003 〈http://www.fda.gov/ohrms/dockets/ dailys/03/Nov03/112803/03n-0472-c000001-vol1.pdf
6. Independent Evaluation of FDA's First Cycle Review Performance- Retrospective Analysis Final Report. Booz Allen Hamilton Inc., January 2006 〈http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/ Studies/ucm201004.htm# ExecutiveSummary
7. Evaluating the Effectiveness of the Food and Drug Administration Modernization Act (a letter from Dr. Timothy R. Franson, MD; Vice President of Clinical ResearcHand Regulatory Affairs at US Lilly Research Laboratories), May 2001 〈http://energycommerce.house.gov/107/hearings/05032001Hearing205/ Franson305.htm
8. Reichert, J.M. Trends in development and approval times for new therapeutics in the United States. Nat. Rev. Drug Discov. 2, 695-702 (2003). (Pubitemid 37361785)
9. DiMasi, J.A., & Faden, L. Factors associated with multiple FDA review cycles and approval phase times. Drug Inform. J. 43, 201 (2009).
10. Sheridan, C. Fresh from the biologic pipeline-2009. Nat. Biotechnol. 28, 307-310 (2010).
11. PAREXEL's Bio/Pharmaceutical Statistical Sourcebook, 2006/2007-2010/2011, (ed. Mathieu, M.). (PAREXEL International Corporation, Waltham, MA) 〈http://www.barnettinternational.com/EducationalServices/Search.aspx?k= PAREXEL%27s +Bio%2fPharmaceutical+R%26D+Statistical+ Sourcebook
12. FY 2006-2010, Performance Report to the President and Congress, Prescription Drug User Fee Act, FDA, DHHS 〈http://www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/default.htm
13. Department of HealtHand Human Services (HHS) Employee Directory online 〈http://directory.psc.gov/employee.htm
14. New Molecular Entity 2010 Statistics, CDER, FDA (slides available online "as is") 〈http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologic ApprovalReports/UCM242695.pdf
15. Goodsaid, F.M.et al. Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact. Nat. Rev. Drug Discov. 9, 435-445 (2010).
16. Eichler, H.-G., Abadie, E., Raine, J.M. & Salmonson, T. Safe drugs and the cost of good intentions. N. Engl. J. Med. 360, 1378-1380 (2009).