Articles by Michael Smedley - Pharmaceutical Technology

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Articles by Michael Smedley

Michael Smedley


Michael Smedley is the branch chief for the Recalls, Shortages and Certificates Branch of CDER's Office of Compliance's Division of Manufacturing and Product Quality.

Articles
FDA Perspectives: An Initial Report of CDER's Recall Root Cause Research Project (Part II)
January 2, 2011

The authors discuss how their research will help FDA in its identification of areas of emphasis in pre- and postapproval evaluation of products and processes.

FDA Perspectives: An Overview of the CDER Drug Recall Root Cause Research Project
August 2, 2009

This article provides an overview of the drug Recall Root Cause Research (RRCR) project, an initiative of the US Food and Drug Administration's Center for Drug Evaluation and Research.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
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