FDA's December 2012 Guidance On IND And BA/BE Reporting - Part II

By Bart Cobert

Continuing with the review of the key points in FDA’s guidance.  This is the second of three postings.

Study Endpoints

If the endpoints are disease-related mortality or major morbidity or “safety endpoints”, the data should be evaluated by a DMC.  The protocol should pre-specify what will be reported as IND safety reports and what is not.  Cases that are specified in the protocol not to be reported should be reported as IND safety reports only if there is evidence suggesting a causal relationship between the drug & the AE.

Editorial Comment: No surprises here.