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An Example of Process Understanding Directed Risk Based CMC Regulatory Oversight of Post-Approval Change

An Example of Process Understanding Directed Risk Based CMC Regulatory Oversight of Post-Approval Change. Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science, CDER, FDA. Process Understanding. Physical, chemical, microbiological, and engineering focus

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Cmc perspective - PowerPoint PPT Presentation

An Example of Process Understanding Directed Risk Based CMC Regulatory Oversight of Post-Approval Change