Regulatory Affairs Professionals Society

Pharma groups say SUPAC guidelines should be updated, better aligned with ICH

Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug ...
RAPS

FDA seeks feedback on overhaul of its SUPAC guidelines

The US Food and Drug Administration (FDA) is seeking public feedback on whether its scale-up and post-approval changes (SUPAC) guidance documents for the pharmaceutical industry need to be updated and ...
Medindia

Genesis of SUPAC

Scale-UP and Post Approval Changes (SUPAC) is an integral part of pharmaceutical product development but till a few years ago, no guidance was Scale-UP and Post Approval Changes (SUPAC) is an integral ...
PharmTech

FDA Releases SUPAC Guidance

Draft guidance combines and supersedes previous guidance documents. Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and ...