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CDRH Industry: FDA Updates Expedited Access Pathway (EAP) Program website

CDRH Industry: FDA Updates Expedited Access Pathway (EAP) Program website

  • matt@madebywink.com
  • September 28, 2016
  • News / US FDA

Today, the U.S. Food and Drug Administration updated the Expedited Access Pathway Program website with two Data Development Plan examples that serve as a resource for sponsors. In April 2015, the FDA…

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FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program

FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program

  • matt@madebywink.com
  • September 9, 2016
  • News / US FDA

Today, the U.S. Food and Drug Administration (FDA) released a draft guidance document entitled “510(k) Third Party Review Program.” The purpose of this draft guidance is to explain the FDA’s…

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  • CDRH Industry: FDA Updates Expedited Access Pathway (EAP) Program website

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