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FDA Public Workshop: In Vitro Diagnostic Testing for Direct Oral Anticoagulants
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When: 9/26/2015
9:00 AM

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This workshop will be held on October 26, 2015 from 9am-5pm at the FDA’s White Oak Campus in Silver Spring. 

Topics for Discussion at the Public Workshop
The public workshop seeks to involve industry and academia in addressing analytical performance requirements for the diagnostic assessment of DOACs.  Furthermore, the workshop aims to focus on the clinical circumstances under which patients receiving these agents would require testing, including but not limited to, the following topic areas: 

  1. Overview of the effects of DOACs on traditional coagulation tests;
  2. identification of clinical scenarios that necessitate DOAC testing;
  3. interpretation of coagulation testing results for patients on DOACs; and
  4. considerations for regulatory review of devices assessing the effect of DOACs on coagulation.

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