Richard L. Friedman

Richard L. Friedman is a microbiologist and is a senior compliance officer for sterile drugs and chairs CDER's Aseptic Processing Guideline Revision Working Group.

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

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.

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.

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.