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Volumn 205, Issue , 2011, Pages 245-268
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Pediatric regulatory initiatives
a
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Author keywords
Deferrals; European Pediatric Regulation; ICH E11 guidelines; Pediatric investigation plan; Pediatric medicines; Pediatric rules; Therapeutic orphans; United States Federal Pediatric Initiatives; Waivers; Written request
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Indexed keywords
AGE SPECIFIC CARE;
ARTICLE;
BEST PHARMACEUTICALS FOR CHILDREN ACT;
CHILD CARE;
CHILD SAFETY;
DRUG DEVELOPMENT;
DRUG LEGISLATION;
DRUG MARKETING;
DRUG SAFETY;
DRUG SURVEILLANCE PROGRAM;
EUROPE;
FOOD AND DRUG ADMINISTRATION;
GOVERNMENT REGULATION;
HUMAN;
PAEDIATRIC COMMITTEE;
PAEDIATRIC INVESTIGATION PLANS;
PATENT;
PEDIATRIC RESEARCH EQUITY ACT;
PEDIATRICS;
PRIORITY JOURNAL;
PROFESSIONAL STANDARD;
RESEARCH SUBJECT;
UNITED STATES;
CLINICAL TRIALS AS TOPIC;
DRUG APPROVAL;
EUROPE;
HISTORY, 20TH CENTURY;
HISTORY, 21ST CENTURY;
HUMANS;
INTERNATIONAL COOPERATION;
LEGISLATION, DRUG;
PEDIATRICS;
PHARMACOVIGILANCE;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 80054919587
PISSN: 01712004
EISSN: 18650325
Source Type: Book Series
DOI: 10.1007/978-3-642-20195-0_12 Document Type: Article |
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Times cited : (28)
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References (6)
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