The impact of the written request process on drug development in childhood cancer

Pediatric Blood and Cancer

Volumn 60, Issue 4, 2013, Pages 531-537

  Snyder, Kristen M ^a   Reaman, Gregory ^a   Avant, Debbie ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Best Pharmaceuticals for Children Act; FDA Modernization Act; Pediatric cancer treatment; Pediatric Drug Development; Written Request

Indexed keywords

ANTINEOPLASTIC AGENT; BUSULFAN; CARBOPLATIN; CLOFARABINE; DOCETAXEL; EVEROLIMUS; FLUDARABINE; FLUDARABINE PHOSPHATE; GEMCITABINE; IMATINIB; IRINOTECAN; NAVELBINE; NELARABINE; OXALIPLATIN; PEMETREXED; TEMOZOLOMIDE; TOPOTECAN;

ACUTE LYMPHOBLASTIC LEUKEMIA; ARTICLE; CANCER CHEMOTHERAPY; CENTRAL NERVOUS SYSTEM TUMOR; CHILD; CHILDHOOD CANCER; CHILDHOOD LEUKEMIA; CHRONIC MYELOID LEUKEMIA; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG EFFICACY; DRUG LABELING; DRUG LEGISLATION; DRUG MARKETING; DRUG PACKAGING; DRUG RESEARCH; DRUG SAFETY; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; HEMATOLOGIC MALIGNANCY; HUMAN; LEUKEMIA; MAXIMUM TOLERATED DOSE; NASOPHARYNX CARCINOMA; PRIORITY JOURNAL; RECURRENT CANCER; SOLID TUMOR; STEM CELL TRANSPLANTATION; SUBEPENDYMAL GIANT CELL ASTROCYTOMA; UNSPECIFIED SIDE EFFECT; WRITTEN REQUEST;

ANTINEOPLASTIC AGENTS; CHILD; DRUG APPROVAL; HUMANS; MARKETING; MEDICAL ONCOLOGY; NEOPLASMS; PEDIATRICS;

EID: 84873713989     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.24346     Document Type: Article

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