Regulatory Landscape for Raw Materials: CMC Considerations
ISPE
AUGUST 30, 2022
During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. 6 US Food and Drug Administration. Burke, S., Hammond, and T.
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