France's new framework for regulating off-label drug use

New England Journal of Medicine

Volumn 367, Issue 14, 2012, Pages 1279-1281

  Emmerich, Joseph ^a   Dumarcet, Nathalie ^a   Lorence, Annie ^a  

^a division surveillance   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BENFLUOREX;

DIABETES MELLITUS; DRUG APPROVAL; DRUG INDICATION; DRUG SAFETY; FRANCE; GOVERNMENT REGULATION; HUMAN; OFF LABEL DRUG USE; PATIENT SAFETY; PRESCRIPTION; PRIORITY JOURNAL; RARE DISEASE; SHORT SURVEY; VALVULAR HEART DISEASE; WEIGHT REDUCTION;

EID: 84867164575     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1208347     Document Type: Article

References (5)

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2. Mullard A. Mediator scandals rocks French medical community. Lancet 2011;377:890-2.
3. Mello MM, Studdert DM, Brennan TA. Shifting terrain in the regulation of off-label promotion of pharmaceuticals. N Engl J Med 2009;360:1557-66.
4. Eichler HG, Pignatti F, Flamion B, Leufkens H, Breckenridge A. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 2008;7:818-26.
5. Ferner RE. Prescribing licensed medicines for unlicensed indications. Prescribers J 1996;36:73-8.