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.
Richard L. Friedman
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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.
Articles by Richard L. Friedman
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- FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic Processing
Published: May 1st 2003 | Updated:
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