FDA PAT Sub-Committee of Advisory Committee for Pharmaceutical Sciences June 12-13, 2002; Gaithersburg, MD Regulatory Challenges: Post-Approval PAT Applications

6/14/02


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Table of Contents

FDA PAT Sub-Committee of Advisory Committee for Pharmaceutical Sciences June 12-13, 2002; Gaithersburg, MD Regulatory Challenges: Post-Approval PAT Applications

Outline

Need for PA-PAT Applications

Challenges in PA-PAT Applications

Challenges in PA-PAT Applications

PA-PAT Applications to APIs

PA-PAT Applications to DPs

Guidance Development for PA-PAT-based Controls CMC Review

Guidance Development for PA-PAT-based Controls Compliance Audit

Summary & Conclusions

Author: nm21291