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Reporting of SUSARs Based on Aggregate Analysis – Statistical Considerations

Michael Zelasky

In December 2015, the FDA released the draft guidance Summary of Assessment for IND Safety Reporting1. The draft guidance includes recommendations on reporting of SUSARs (Serious and Unexpected Suspected Adverse Reactions) based on aggregate analysis. Aggregate analysis is stated in the Code...

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US FDA Updates Draft Guidance on Comparability Protocols for Human Drugs and Biologics (Chemistry, Manufacturing, and Controls Information)

Vivek Padalalu

The United States Food and Drug Administration (FDA) has released a draft Guidance on “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”, Revision 1, dated 19 April 2016. This guidance provides human drugs and biologics application holders with...

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