Harvard Catalyst | The Clinical Translational Science Center IND/IDE Consult Service: Providing an IND/IDE Consult Service in a Decentralized Network of Academic Healthcare Centers

Abstract The Food and Drug Administration (FDA) regulations require sponsors of clinical investigations involving an investigational drug or device to submit an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. Strict adherence to applicable regulations is vital t...

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Bibliographic Details
Published in:Clinical and Translational Science
Main Authors: Min J. Kim, Sabune J. Winkler, Barbara E. Bierer, Delia Wolf
Format: Article
Language:English
Published: Wiley 2014-04-01
Subjects:
translational research
clinical trials
FDA
Online Access:https://doi.org/10.1111/cts.12146

Internet

https://doi.org/10.1111/cts.12146

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