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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.

US FDA Updates Draft Guidance on Comparability Protocols for Human Drugs and Biologics (Chemistry, Manufacturing, and Controls Information)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The United States Food and Drug Administration (FDA) has released a draft Guidance on “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”, Revision 1, dated 19 April 2016.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FDA issues New Draft Guidance on Data Integrity and Compliance with cGMP


Vivek Padalalu

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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