ICH M7(R1) - Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment

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  • Опубликовано: 12 сен 2024
  • FDA outlines the key concepts surrounding hazard assessment and impurity classification per ICH M7.
    Presenter:
    Barbara O. Scott, Division of Lifecycle API
    Learn more at: www.fda.gov/dr...
    -------------------- 
    FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
     
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    Phone - (301) 796-6707 I (866) 405-5367

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