Blog

Sciformix is committed to sharing ideas and insights with the life science industry and support the development and commercialization of safe and effective products. Our employees and partners share their knowledge and thought leadership.

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Reporting of SUSARs Based on Aggregate Analysis – Statistical Considerations

Posted Clinical Development and Post Approval Support Services Blog


Michael Zelasky
Principal, Global Biometrics

In December 2015, the FDA released the draft guidance Summary of Assessment for IND Safety Reporting1. The draft guidance includes recommendations on reporting of SUSARs (Serious and Unexpected Suspected Adverse Reactions) based on aggregate analysis.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US FDA Updates Draft Guidance on Comparability Protocols for Human Drugs and Biologics (Chemistry, Manufacturing, and Controls Information)

Posted Regulatory Affairs Blog


Vivek Padalalu
Delivery Manager, Scientific Writing and Regulatory Affairs

The United States Food and Drug Administration (FDA) has released a draft Guidance on “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”, Revision 1, dated 19 April 2016.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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FDA issues New Draft Guidance on Data Integrity and Compliance with cGMP

Posted Regulatory Affairs Blog


Vivek Padalalu
Delivery Manager, Scientific Writing and Regulatory Affairs

The mission of all health authorities is to ensure the quality, safety and efficacy of drug products by carefully monitoring drug manufacturers’ compliance with their current Good Manufacturing Practice (cGMP) regulations. The cGMP regulations for drugs contain minimum requirements for the methods,...

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