How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers' views

Annals of Oncology

Volumn 25, Issue 1, 2014, Pages 265-269

  Tafuri, G ^a,b   Stolk, P ^b   Trotta, F ^a   Putzeist, M ^b   Leufkens, H G ^b,c   Laing, R O ^d   de Allegri, M ^e  

^a ITALIAN MEDICINES AGENCY   (Italy)

^b UTRECHT UNIVERSITY   (Netherlands)

^c MEDICINES EVALUATION BOARD   (Netherlands)

^d WORLD HEALTH ORGANIZATION   (Switzerland)

^e UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Anticancer medicines; EMA; FDA; Interview study; Qualitative research; Regulatory

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; ATTITUDE; COMPARATIVE STUDY; COOPERATION; DECISION MAKING; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HUMAN; PRIORITY JOURNAL; QUALITATIVE RESEARCH; QUALITY OF LIFE; RISK BENEFIT ANALYSIS; SAFETY; SEMI STRUCTURED INTERVIEW; TELECONFERENCE;

ANTICANCER MEDICINES; EMA; FDA; INTERVIEW STUDY; QUALITATIVE RESEARCH; REGULATORY;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DECISION MAKING; DRUG APPROVAL; EUROPE; HUMANS; NEOPLASMS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84905388371     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdt512     Document Type: Article

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