CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 7, 2024
The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)
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