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

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 to the suc...

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Main Authors: Kim, Min J., Winkler, Sabune J., Bierer, Barbara E., Wolf, Delia
格式: Artigo
語言:Inglês
出版: John Wiley and Sons Inc. 2014
主題:
Research Articles
在線閱讀:https://ncbi.nlm.nih.gov/pmc/articles/PMC4040953/
https://ncbi.nlm.nih.gov/pubmed/24455986
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12146
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