Current status of the FDA approval process: comparison of requirements for pediatric and adult patients.
Robie-Suh
K M
KM
Division of Gastrointestinal & Coagulation Drug Products, Food and Drug Administration, Rockville, Maryland, USA. robiesuh@cder.fda.gov
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D007223:Infant; D014481:United States; D014486:United States Food and Drug Administration