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Regulatory Consulting & Drug Development

Regulatory Consulting and IND Development

The Preclinical Research Development program consults with investigators on the scientific information required to support an Investigational New Drug application to FDA.  This includes characterization of the product, animals models of safety or efficacy, or toxicology.  In addition, the ITHS Preclinical Research Development team will consult on the content of the IND application and FDA interactions in general.  This support currently includes review of pre-IND and IND applications.

In some cases it may be advisable to present your program to the Drug and Device Advisory Committee DDAC for preliminary review of the preclinical data supporting the application.

Fees

Fees

This consultation is limited to four (4) hours and is not charged to the applicants. Future management or oversight of the IND must be built into the funding mechanisms for the program.

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Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.