Drug Advocacy, Device Public Workshop, FDA Monthly Track – Drug and Device Digest



To provide a focal point for advocacy, to enhance two-way communication and collaboration with healthcare professionals, patients, patient groups, and others on CDER issues concerning drug development, drug review, and drug safety.


PUBLIC WORKSHOP : In Vitro Diagnostic Testing for Direct Oral Anticaogulants

The Food and Drug Administration (FDA) is announcing a public workshop entitled “In Vitro Diagnostic Testing for Direct Oral Anticoagulants”. The objective of the workshop is to discuss analytical performance requirements for the diagnostic assessment of direct oral anticoagulants (DOACs), and the clinical circumstances under which patients receiving these agents would require testing. Specifically, this workshop aims to 1) evaluate the impact of DOACs on traditional coagulation testing results; 2) identify clinical circumstances where testing of DOACs anticoagulant activity or concentration would be relevant; 3) discuss clinically meaningful interpretation of coagulation testing results for patients on DOACs; and 4) review the regulatory requirements for granting clearance for in vitro diagnostic devices intended for coagulation testing in patients treated with DOACs.


FDA MONTHLY TRACK: Agency-wide Program PerformanceFDA Track

FDA Track 2


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