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PDA ANSI

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.
Lori Richter Volunteer Spotlight Volunteer of the Month is Claire Fritz Briglia
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