New FDA Safety Requirements: Question on timing and how it affects current INDs and clinical studies

Dr. Shailesh C. Comment and Question:

“Excellent comments. I completely agree that the new guidance on safety reporting helps Sponsor’s on better judgment and possibility to make better assessments. It means Sponsor’s have to monitor the clinical studies, any post marketing trial data, etc., from other products in same class to do safety signal and risk/ benefit assessment. Since this goes into effect end of March 2011, it is not clear how on-going clinical trials get affected (since there are implications to include any known adverse drug reactions in the protocol and informed consent).”

Michael Silverman, MD, FACP • Great question, thank you! I had the same concern, so I asked several of my drug safety contacts. The answer is that the new regulation comes into effect for all open INDs and protocols on March 28th, 2011. So some protocols, and certainly many SOPs, may be candidates for revisions or amendments. I hope this answers your question. MS.”

Copyright © 2011 BioStrategics Consulting Ltd.



About BioStrategics Consulting Ltd

BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical and biotechnology industries
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