FDA center for drug evaluation and research (CDER) pediatric plan and new regulations

Drug Information Journal

Volumn 30, Issue 4, 1996, Pages 1125-1127

  Roberts, Rosemary ^a,b   Maldonado, Samuel ^a  

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

^b Center for Drug Evaluation and Research   (United States)

Author keywords

CDER Pediatric Drug Development Plan; CDER Pediatric Working Groups; Pediatric labeling regulation

Indexed keywords

NEW DRUG;

CHILD; DRUG APPROVAL; DRUG CONTROL; DRUG INDICATION; DRUG INFORMATION; DRUG LABELING; DRUG LEGISLATION; DRUG PROGRAM; DRUG RESEARCH; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HUMAN; INFANT; PRIORITY JOURNAL; REVIEW;

EID: 0029849222     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000430     Document Type: Review

References (1)

1. Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of "Pediatric Use" Subsection in the Labeling; Final Rule. Federal Register. 1994;59(238):64240-50.