Pediatric oncology: Regulatory initiatives

Oncologist

Volumn 5, Issue 6, 2000, Pages 441-444

  Hirschfeld, S ^a   Shapiro, A ^a   Dagher, R ^a   Pazdur, R ^a  

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

Author keywords

FDA regulations; Pediatric; Pediatric oncology; Protocols

Indexed keywords

CANCER THERAPY; CHILDHOOD CANCER; CLINICAL PROTOCOL; DRUG INFORMATION; DRUG PACKAGING; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; REVIEW; TREATMENT INDICATION;

EID: 0033663596     PISSN: 10837159     EISSN: None     Source Type: Journal    
DOI: 10.1634/theoncologist.5-6-441     Document Type: Review

References (6)

1. Specific requirements on content and format of labeling for human prescription drugs; Revision of 'Pediatric Use' subsection in the labeling; final rule
2. Pediatric patients; regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products; final rule