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September 27, 2024

CDER Nitrosamine Impurity Acceptable Intake Limits

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Guidance for Industry Control of Nitrosamine Impurities in Human Drugs Guidance for Industry Subscribe for email […]
September 27, 2024

Critical Path Innovation Meetings (CPIM)

Hello. In this presentation, I will discuss the Critical Path Innovation Meeting, otherwise known as CPIM,  program, including goals of the program, how to request a […]
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