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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  • U.S. FDA has issued a draft guidance for public comment regarding the Abbreviated 510(k) Program.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
Borke Van Belle Volunteer Spotlight Volunteer of the Month is Sateesh Yelisetti
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