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Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold

Larissa Lapteva, Anne R Pariser
DOI: 10.1136/jim-2015-000010 Published 28 January 2016
Larissa Lapteva
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
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Anne R Pariser
2Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USA
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Article Information

vol. 64 no. 2 376-382
DOI 
https://doi.org/10.1136/jim-2015-000010
PubMed 
26911627

Print ISSN 
1081-5589
Online ISSN 
1708-8267
History 
  • Received November 4, 2015
  • Revised December 3, 2015
  • Accepted December 16, 2015
  • Published online January 28, 2016.

Copyright & Usage 
Copyright © 2016 American Federation for Medical Research

Author Information

  1. Larissa Lapteva1,
  2. Anne R Pariser2
  1. 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
  2. 2Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USA
  1. 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
Journal of Investigative Medicine: 64 (2)
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Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold
Larissa Lapteva, Anne R Pariser
Journal of Investigative Medicine Feb 2016, 64 (2) 376-382; DOI: 10.1136/jim-2015-000010

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Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold
Larissa Lapteva, Anne R Pariser
Journal of Investigative Medicine Feb 2016, 64 (2) 376-382; DOI: 10.1136/jim-2015-000010
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Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold
Larissa Lapteva, Anne R Pariser
Journal of Investigative Medicine Feb 2016, 64 (2) 376-382; DOI: 10.1136/jim-2015-000010
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