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Expert Analysis

Parsing Pros And Cons Of FDA's Expedited Access Pathway

Law360, New York (May 14, 2015, 10:47 AM EDT) -- The U.S. Food and Drug Administration initiated an expedited access pathway ("EAP") program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications or de novo requests. The FDA formally established the EAP program through a final guidance document, "Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions" ("EAP Guidance"), issued on April 13, 2015.[1]...

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