Available tools to facilitate early patient access to medicines in the EU and the USA: Analysis of conditional approvals and the implications for personalized medicine

Public Health Genomics

Volumn 18, Issue 5, 2015, Pages 249-259

  Leyens, Lada ^a   Richer, Étienne ^b   Melien, Øyvind ^c   Ballensiefen, Wolfgang ^d   Brand, Angela ^a  

^a MAASTRICHT UNIVERSITY   (Netherlands)

^b CIHR Institute of Genetics   (Canada)

^c Norwegian Directorate of Health   (Norway)

^d GERMAN AEROSPACE CENTER DLR   (Germany)

Author keywords

Accelerated approval; Conditional approval; Drug development; Early patient access; European Medicines Agency; Food and Drug Administration; Health technology assessment; Personalized medicine; Regulation

Indexed keywords

ARTICLE; CLINICAL EVALUATION; COST EFFECTIVENESS ANALYSIS; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HUMAN; LEGAL ASPECT; MARKETING; MEDICAL INFORMATION; PERSONALIZED MEDICINE; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; RISK FACTOR; UNITED STATES; CLINICAL TRIAL (TOPIC); COST BENEFIT ANALYSIS; DRUG APPROVAL; DRUG DEVELOPMENT; ECONOMICS; EUROPE; EUROPEAN UNION; FINANCIAL MANAGEMENT; FORECASTING; HEALTH CARE DELIVERY; LEGISLATION AND JURISPRUDENCE; MEDICAL RESEARCH; MEDICAL SOCIETY; ORGANIZATION AND MANAGEMENT; PROCEDURES; RISK ASSESSMENT;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; COST-BENEFIT ANALYSIS; DRUG APPROVAL; DRUG DISCOVERY; EUROPE; EUROPEAN UNION; FORECASTING; HEALTH SERVICES ACCESSIBILITY; HUMANS; MARKETING OF HEALTH SERVICES; PRECISION MEDICINE; RISK ASSESSMENT; SOCIETIES, MEDICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84945479824     PISSN: 16624246     EISSN: 16628063     Source Type: Journal    
DOI: 10.1159/000437137     Document Type: Article

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