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Question-based review for CMC evaluations of ANDAs

  • At: Salvadore (Brazil) (2006)
  • Type: Presentation
  • By: RAW, Andre (Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, United States of America)
  • Abstract:

    The Office of Generic Drugs (OGD) is developing a question-based review (QbR) for the Chemistry, Manufacturing, and Controls (CMC) evaluation of an Abbreviated New Drug Application (ANDA) that is focused on critical pharmaceutical quality attributes. The QbR will transform the CMC review into a modern, science and risk-based pharmaceutical quality


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Last update 4 October 2019

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