Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
ISPE
JULY 6, 2023
1 , 2 The FDA has been prioritizing advanced manufacturing and adding staff to its Emerging Technology platform, but regulation expectations from other markets (e.g., Generics and Biosimilars Initiative Journal 10, no. China and Brazil) can add resistance to approvals. Siang, and C. 1 (March 2021):44–56. doi:10.5639/gabij.2021.1001.004
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