Regulatory Landscape for Raw Materials: CMC Considerations
ISPE
AUGUST 30, 2022
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. 6 US Food and Drug Administration. Burke, S., Hammond, and T.
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