Article Information
vol. 64 no. 2 376-382
PubMed
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History
- Received November 4, 2015
- Revised December 3, 2015
- Accepted December 16, 2015
- Published online January 28, 2016.
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Copyright © 2016 American Federation for Medical Research
Author Information
- 1Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA
- 2Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USA
- Correspondence to Dr Anne Pariser, Office of Translational Sciences, CDER, FDA, 10903 New Hampshire Avenue, WO21-4607, Silver Spring, MD 20993, USA, anne.pariser{at}fda.hhs.gov
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Vol 64 Issue 2
Table of Contents
Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold
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