An Evaluation of Postapproval CMC Change Timelines
ISPE
SEPTEMBER 10, 2023
These long global approval timelines complicate supply chain management by delaying innovations that improve quality assurance and by increasing the potential for supply interruptions and shortages that impact patient access to products. Pharmaceutical Engineering 42, no. 1 (January/February 2022). Cauchon, T. Hedberg, M.
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