Flexibility in the FDA approach to orphan drug development

Nat Rev Drug Discov. 2017 Nov;16(11):737-738. doi: 10.1038/nrd.2017.151. Epub 2017 Sep 1.

Authors

Nina L Hunter¹, Gayatri R Rao¹, Rachel E Sherman¹

Affiliation

¹ Office of the Commissioner at the US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.

PMID: 28860647
DOI: 10.1038/nrd.2017.151

No abstract available

MeSH terms

Drug Approval / methods*
Drug Development / methods*
Drug Development / trends
Humans
Orphan Drug Production / methods*
Rare Diseases / drug therapy
United States
United States Food and Drug Administration