The AAPS journalHumansDrug ApprovalPharmaceutical PreparationsWorld Health OrganizationDrug Industry
Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP.
Sunny Kamlesh Dave, Christine Ørting, Scott W Roberts
Published: 202510.1208/s12248-025-01133-7
Abstract
The efficient review and approval of chemistry, manufacturing and control (CMC) post-approval changes by global health authorities remains a critical aspect toward ensuring medical product commercial supply chains and patient access. The recent and g…
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