Discussion: Is the FDA in need of a major change in the way it regulates?

Biostatistics. 2017 Jul 1;18(3):414-416. doi: 10.1093/biostatistics/kxx022.

Author

Susan S Ellenberg¹

Affiliation

¹ Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.

PMID: 28633289
DOI: 10.1093/biostatistics/kxx022

No abstract available

MeSH terms

Biomarkers*
Clinical Trials as Topic*
Drug Approval*
Humans
United States
United States Food and Drug Administration* / legislation & jurisprudence
United States Food and Drug Administration* / organization & administration
United States Food and Drug Administration* / standards

Substances

Biomarkers