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Risk Based CMC Review

Risk Based CMC Review. Advisory Committee for Pharmaceutical Science October 22, 2003 Vilayat A. Sayeed , Ph.D. OGD, FDA . Risk Based CMC Review. General Principle Scope Drug Substance Attributes for risk qualification Drug Product Attributes for risk qualification.

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661 views • 20 slides

Risk Based CMC Review An Update

Risk Based CMC Review An Update . ACPS Meeting October 21, 2002 Yuan-yuan Chiu, Ph.D. Director, ONDC/OPS, FDA. Objectives. To compile a list of drugs (low risk with respect to quality) that will qualify for the elimination of most of NDA/ANDA manufacturing supplements

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170 views • 6 slides

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Ds dp - PowerPoint PPT Presentation

Risk Based CMC Review

Risk Based CMC Review An Update