Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance

JAMA. 2017 Feb 21;317(7):693-694. doi: 10.1001/jama.2017.0410.

Author

Robert M Califf¹

Affiliation

¹ Formerly with the US Food and Drug Administration, Silver Spring, Maryland.

PMID: 28114599
DOI: 10.1001/jama.2017.0410

No abstract available

MeSH terms

Clinical Trials as Topic
Decision Making
Device Approval / legislation & jurisprudence
Device Approval / standards*
Drug Approval* / legislation & jurisprudence
Humans
Risk Assessment / legislation & jurisprudence
Risk Assessment / standards*
Uncertainty
United States
United States Food and Drug Administration / standards*