A clinical pharmacology-regulatory perspective on the approval of drugs for rare diseases-Reference-Cited by-同舟云学术

A clinical pharmacology-regulatory perspective on the approval of drugs for rare diseases

Published:2016-08-26 Issue:4 Volume:100 Page:327-329
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Bashaw ED¹

Affiliation:

1. Division of Clinical Pharmacology-3, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference10 articles.

1. http://www.fda.gov/regulatoryinformation/legislation/significantamendmentstothefdcact/orphandrugact/default.htm

2. Principles of early drug discovery;Hughes;Br. J. Pharmacol.,2011

3. http://cdn.rarediseases.org/wordpresscontent/wp-content/uploads/2014/12/NORD-study-of-FDA-approval-of-orphan-drugs.pdf

4. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458485.pdf

5. Clinical pharmacology and orphan drugs: an informational inventory 2006-2010;Bashaw;Clin. Pharmacol. Ther.,2012

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