Commentary: Epidemiology and the pharmaceutical industry: An inside perspective

International Journal of Epidemiology

Volumn 37, Issue 1, 2008, Pages 53-55

  Haas, Joanna ^a  

^a GENZYME CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ADVISORY COMMITTEE; AWARENESS; CONFLICT OF INTEREST; CONSULTATION; DECISION MAKING; DRUG APPROVAL; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EPIDEMIOLOGICAL DATA; FOOD AND DRUG ADMINISTRATION; FUNDING; HIGH RISK POPULATION; MEDICAL INFORMATION; MEDICAL RESEARCH; MEDICAL SOCIETY; NOTE; PATIENT SAFETY; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLICATION; PUBLISHING; REIMBURSEMENT; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT;

CONFLICT OF INTEREST; DRUG APPROVAL; DRUG INDUSTRY; FEMALE; HUMANS; INTERPROFESSIONAL RELATIONS; MALE; PHARMACOEPIDEMIOLOGY; PROFESSIONAL CORPORATIONS; QUALITY CONTROL; RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 38949213991     PISSN: 03005771     EISSN: 14643685     Source Type: Journal    
DOI: 10.1093/ije/dym264     Document Type: Note

References (11)

1. Pearce N. Corporate influences on epidemiology. Int J Epidemiol 2008;37:46-53.
2. Pearce N. Adverse Reactions- The Fenoterol Story. Auckland: Auckland University Press; 2007.
3. International Conference on Harmonization. E2E Pharmacovigilance Planning. LondoH: EMEA 2005. Available at: http://www.emea.europa.eu/ pdfs/human/ich/571603en.pdf
4. Committee for Medicinal Products for Human Use. Guideline on Risk Management Systems for Medicinal Products for Human Use. London: EMEA 2005. Available at: http://www.emea.europa.eu/pdfs/human/euleg/ 9626805en.pdf
5. European Medicines Agency. Post-authorisation Evaluation of Medicines for Human Use. LHndon: EMEA, 2006; Available at: http://www.emea.europa.eu/pdfs/human/euleg/19263206en.pdf (Accessed 9 July, 2007).
6. Food and Drug Administration. Guidance for Industry: Premarketing Risk Assessment. Maryland: FDA 2005. Available at: http://www.fda.gov/CDER/guidance/6357fnl.htm
7. International Conference on Harmonization. Guideline for Good Clinical Practice: E6 RI.
8. Stossel TP, Thomas P. Regulating academic-industrial research relationships - solving problems or stifling progress? NEJM 2005;353:1060-65.
9. Haas JF, Staudinger HW, Schuijt C. Letter to the editor. BMJ 1992;304:1634.
10. Gottlieb, Scott. Journalistic malpractice. Wall Str J 2007 A15; May 29.
11. Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety. Washington DC: Institute of Medicine, The National Academies Press, 2007.