Articles by Richard L. Friedman - Pharmaceutical Technology

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Articles by Richard L. Friedman

FDA/Industry Perspectives: Detection, Measurement, and Control in Manufacturing

The authors summarize a recent FDA–PQRI workshop on process drift.
Oct 2, 2011

The authors summarize a recent FDA–PQRI workshop on process drift.

FDA Perspectives: An Initial Report of CDER's Recall Root Cause Research Project (Part II)

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.
Jan 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

Aug 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.

FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic Processing

May 1, 2003

The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.

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