Premarket safety population size associated with approval of expedited program drugs and orphan drugs

J Clin Epidemiol. 2019 Sep:113:101-103. doi: 10.1016/j.jclinepi.2019.04.021. Epub 2019 May 15.

Author

Affiliation

¹ Office of Scientific Investigations, Office of Compliance, The Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Kachikwu.illoh@fda.hhs.gov.

PMID: 31102646
DOI: 10.1016/j.jclinepi.2019.04.021

No abstract available

Publication types

Letter
Observational Study

MeSH terms

Drug Approval / statistics & numerical data*
Humans
Marketing / statistics & numerical data*
Orphan Drug Production / standards*
Orphan Drug Production / statistics & numerical data*
Patient Safety / standards*
Patient Safety / statistics & numerical data*
Prescription Drugs / standards*
United States
United States Food and Drug Administration

Substances

Prescription Drugs