Current status of the FDA approval process: comparison of requirements for pediatric and adult patients

Inflamm Bowel Dis. 1998 May;4(2):103-4. doi: 10.1097/00054725-199805000-00008.

Author

K M Robie-Suh¹

Affiliation

¹ Division of Gastrointestinal & Coagulation Drug Products, Food and Drug Administration, Rockville, Maryland, USA. robiesuh@cder.fda.gov

PMID: 9687212
DOI: 10.1097/00054725-199805000-00008

No abstract available

Publication types

Comparative Study

MeSH terms

Adolescent
Adult
Age Factors
Child
Drug Evaluation / legislation & jurisprudence*
Drug Labeling / legislation & jurisprudence*
Humans
Infant
United States
United States Food and Drug Administration*