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New FDA Guidance Documents

Two new guidance documents have been posted to the FDA Clinical Trials Guidance Documents.

Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies - Guidance for Industry and Investigators 

Safety Requirements for INDs and BA/BE Studies-Small Entity Compliance Guide - for Industry and Investigators

If you have questions over this new guidance, please contact the Human Subjects Office at irb@uiowa.edu or 319-335-6564

 


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Hardin Library, Office 105
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Iowa City, IA 52242-1098

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irb@uiowa.edu

 

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