The authors reply

New England Journal of Medicine

Volumn 371, Issue 1, 2014, Pages 89-90

  Darrow, Jonathan J ^a   Avorn, Jerry ^a   Kesselheim, Aaron S ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GEMTUZUMAB OZOGAMICIN; NEW DRUG;

DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HUMAN; LETTER; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; LEGAL ASPECT; NOTE; STANDARD;

DRUG APPROVAL; DRUGS, INVESTIGATIONAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84903703820     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc1405337     Document Type: Letter

References (4)

1. Investigational new drug, antibiotics, and biological drug product regulations: procedures for drugs intended to treat lifethreatening and severely debilitating illnesses. Fed Regist 1988;53:41516-24.
2. Food and Drug Administration. Guidance for industry: expedited programs for serious conditions - drugs and biologics. July 2013 (http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf) .
3. Avorn J. The promise of pharmacoepidemiology in helping clinicians assess drug risk. Circulation 2013;128:745-8.
4. Outterson K, Powers JH, Seoane-Vazquez E, Rodriguez-Monguio R, Kesselheim AS. Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009. J Law Med Ethics 2013;41:688-96.