A regulatory overview about rare diseases

Advances in Experimental Medicine and Biology

Volumn 686, Issue , 2010, Pages 193-207

  Llinares, Jordi ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Conditional marketing authorization; Drug development; Exceptional circumstances; Incentives; Orphan designation; Orphan regulation

Indexed keywords

ORPHAN DRUG;

AUSTRALIA; DRUG APPROVAL; DRUG EFFICACY; DRUG INFORMATION; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; EVIDENCE BASED MEDICINE; FINANCIAL MANAGEMENT; HUMAN; JAPAN; PHARMACOEPIDEMIOLOGY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; RARE DISEASE; REVIEW; RISK BENEFIT ANALYSIS; UNITED STATES; DRUG DEVELOPMENT; DRUG MANUFACTURE; INTERNATIONAL COOPERATION; LEGAL ASPECT;

AUSTRALIA; DRUG APPROVAL; DRUG DISCOVERY; EUROPEAN UNION; HUMANS; INTERNATIONAL AGENCIES; JAPAN; ORPHAN DRUG PRODUCTION; PHARMACOEPIDEMIOLOGY; RARE DISEASES; UNITED STATES;

EID: 79952048284     PISSN: 00652598     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-90-481-9485-8_12     Document Type: Review

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