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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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Autori principali: Kim, Min J., Winkler, Sabune J., Bierer, Barbara E., Wolf, Delia
Natura: Artigo
Lingua:Inglês
Pubblicazione: John Wiley and Sons Inc. 2014
Soggetti:
Accesso online: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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