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