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IND

Question tag: IND 58 Questions

0 Votes 1 Ans

How can I learn how to file IND? Any specific contacts at the FDA?

contacts fda file IND learn

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What is the Investigational New Drug (IND) process?

drug IND investigational process

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What is CGIRBs policy for reporting IND Safety reports?

CGIRB IND policy reports safety

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What is the policy for reporting IND Safety reports?

IND policy reports safety

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Is the path to Food and Drug Administration (FDA)/Investigational New Drug ( IND ) clearance the same as that for other Australian biotechnology companies or global pharmaceutical companies?

Australian clearance drug fda Food and Drug Administration IND investigational path

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What if IND approval is cannot obtained at the time of award notification?

Approval award IND NOTIFICATION obtained time

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When is IND approval required to be in effect? At the time of the full proposal submission or before an award is forthcoming?

Approval award forthcoming IND proposal submission time

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How can I determine if an Investigational New Drug Application (IND) is required for my study?

application determine drug IND investigational study

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How to decide if an IND / IDE may be needed?

decide IDE IND needed

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What happened to the Compassionate IND program?

alternative compassionate Fitness happened Health IND Medicine program

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Can an IND with a phase 3 study be submitted when the non-U.S. phase 1 and 2 studies were not conducted under an IND?

conducted IND non-U.S phase study submitted

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How does the FDA use NCL data when an NCL collaborator submits an Investigational New Drug (IND) filing?

collaborator Data drug fda filing IND investigational ncl submits

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Are Investigational New Drug (IND) applications required for clinical studies of botanical products that are also lawfully marketed as dietary supplements in the U.S.?

applications Botanical clinical drug IND investigational products

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What is ITU IND AESA?

aesa IND itu

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What makes IND Tactical Outsourcing Superior?

healthcare consulting IND outsourcing outsourcing medical billing superior tactical

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What is the Zelnorm treatment IND program?

IND program treatment zelnorm

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What Are Mission Statements For?

assoc Association IND independent mission nais nat'l National schools statements

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Which FDA office may an IRB contact to determine whether an investigational new drug application (IND) or investigational device exemption (IDE) is required for a study of a test article?

application contact determine drug fda IND investigational IRB Office

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What is an IND?

IND

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Do you work at Procomp Amazonia Ind Elet Ltda?

amazonia elet IND procomp