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Risk Based CMC Review Current Thinking - Overview

Risk Based CMC Review Current Thinking - Overview. ACPS Meeting Oct. 21-22, 2003 Yuan-yuan Chiu, Ph.D. OBP/OPS/CDER/ FDA. Overall Objective. To incorporate scientific based risk-assessment and risk-management to CMC submission review Current thinking: Intrinsically low risk drugs

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Risk Based CMC Review Current Thinking - Overview

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  1. Risk Based CMC ReviewCurrent Thinking - Overview ACPS Meeting Oct. 21-22, 2003 Yuan-yuan Chiu, Ph.D. OBP/OPS/CDER/ FDA

  2. Overall Objective • To incorporate scientific based risk-assessment and risk-management to CMC submission review • Current thinking: Intrinsically low risk drugs • Expanded approach: Focused on “process understanding”

  3. Goal of Project #1 • 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 • reduced CMC information needed to be submitted to an original ANDA (Truncated ANDA - TANDA) and AR to an approved NDA/ANDA/TANDA

  4. Internal Discussion ACPS Meeting Scientific Workshop CMCCC & CCC Scientific Rounds Brown bag meetings November, 2000 July, 2001, October, 2002 AAPS Workshop - June, 2001 DIA Annual Meeting - June, 2003 Background

  5. Tier 1 Tier 2 Tier 3 1A. To establish attributes and acceptance criteria 1B. To propose a drug list 2A. To finalize the drug list after medical consultation 2B. To eliminate supplements for most PAC, and to reduce data package to be submitted to AR 3. To determine a firm’s eligibility by evaluating its GMP compliance A Three-Tier Process

  6. General Principleto Define Low Risk Drugs Low Probability of Detection Medium High Low Risk High Low Medium Complexity* *DS/DP characterization Mechanism of product performance Manufacturing technology

  7. Eric Duffy Paul Schwartz Marie Kowblansky Scott Furness Mayra Pineiro-Sanchez Haripada Sarker Rao Puttagunta Vilayat Sayeed Dan Boring Liang Zhou Sheldon Markofsky Davinder Gill Sung Kwang Kim Members of Sub-working GroupsDrug Substance Drug Product

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