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  2. IND/IDE

IND/IDE

IND Confirmation that it’s OK to Proceed

Posted on April 2, 2019

IND_Confirmation that it's OK to Proceed _Letter_2019

File: IND_Confirmation-that-its-OK-to-Proceed-_Letter_2019.docx

IDE Formal Progress Report

Posted on January 11, 2018

Investigational Device Exemption Formal Progress Report Template

File: IDE_Formal_Progress_Report-2018.doc

IDE Informal Progress Report

Posted on January 11, 2018

Investigational Device Exemption Informal Progress Report Template

File: IDE_Informal_Progress_Report-2018.doc

IDE Application Cover Letter

Posted on January 11, 2018

Investigational Device Exemption Application Cover Letter Template

File: IDE_Application-Cover_Letter_2018.docx

IDE Application Template

Posted on January 11, 2018

Investigational Device Exemption Application Template

File: IDE_Application_Template_2018.docx

Pre-IND Briefing Packet Template

Posted on January 11, 2018

Pre-IND Briefing Packet Template

File: Pre-IND_Briefing_Packet-Template-2018.docx

Request for Pre-IND Meeting Template

Posted on January 11, 2018

Request for Pre-IND Briefing Meeting Template

File: Request_For_Pre-IND_Meeting-Template-2018.docx

IND Exemption Letter Brief

Posted on January 11, 2018

Investigational New Drug IND Exemption Letter brief version

File: IND_Exemption_Letter-Brief-2018.docx

IND Exemption Letter Long

Posted on January 11, 2018

Investigational New Drug IND Exemption Letter long version

File: IND_Exemption_Letter-Long-2018-1.docx

IND Safety Report Cover Letter

Posted on January 11, 2018

Investigational New Drug Safety Report Cover Letter

File: IND_Safety_Report-Cover_Letter-2018.docx
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  • Institute for Clinical and Translational Research
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The Institute for Clinical and Translational Research is supported by the Clinical and Translational Science Award (CTSA) program, the National Center for Advancing Translational Sciences (NCATS), grant 1UL1TR002373.

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