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What's New
  • New online content just added to the PDA Letter! Jeffery Odum, NNE, explains how companies can modify their manufacturing practices for patient-centric product.
  • U.S. FDA has issued a draft guidance for public comment regarding the Abbreviated 510(k) Program. This guidance offers a more efficient and less burdensome 510(k) pathway to enable submitters to demonstrate substantial equivalence of moderate-risk devices to devices already on the market.
  • Read PDA’s comments on the draft revision of EU GMP Annex 1.
PDA Technical Report No. 79
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About PDA

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its nearly 10,000 members worldwide.

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