Regulatory review of new therapeutic agents - FDA versus EMA, 2011-2015

New England Journal of Medicine

Volumn 376, Issue 14, 2017, Pages 1386-1387

  Downing, Nicholas S ^a   Zhang, Audrey D ^b   Ross, Joseph S ^c  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG APPROVAL; DRUG CLASSIFICATION; DRUG CONTROL; DRUG INDICATION; DRUG RESEARCH; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HEMATOLOGIC DISEASE; HUMAN; LETTER; MALIGNANT NEOPLASM; EUROPE; LEGISLATION AND JURISPRUDENCE; STATISTICS AND NUMERICAL DATA; TIME FACTOR; UNITED STATES;

DRUG APPROVAL; EUROPE; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85017286010     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc1700103     Document Type: Letter

References (3)

1. H.R.34 - 21st Century Cures Act, 114th Congress (2015-2016). December 13, 2016 (https://www.congress.gov/bill/114th-congress/house-bill/34).
2. Avorn J. Paying for drug approvals - who's using whom? N Engl J Med 2007; 356: 1697-700.
3. Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics - comparison of three regulatory agencies. N Engl J Med 2012; 366: 2284-93.