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PDA and the American National Standards Institute (ANSI)

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What's New
  • Commenting opportunity - revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
  • New online content just added to the PDA Letter! "Big Data" and “Manufacturing Intelligence” are two popular "buzzwords" often used when mentioning the future of bio/pharmaceutical manufacturing, but what do they mean? In the latest “On the Issue” video, Aaron Goerke, Genentech/Roche, explains what these terms mean for this industry.
  • U.S. FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, Director, CDER, U.S. FDA, have announced that the Agency has developed a comprehensive three-way approach to ensure patient access to safe medicines that focuses on preventing shortages, early identification of anticipated shortages, and remedying the underlying problems when shortages arise.
  • Comments are due May 15, 2019 on a new EMA guidance detailing the pharmaceutical use of different grades of water in the manufacture of APIs and medicinal products.
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