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FDA Promotes Clinical Trial Innovation

As the U.S. Food and Drug Administration observes Clinical Trials Day, we reflect on the progress made and the widespread efforts underway to advance clinical trial innovation.

United statesHilary marstonKevin buginDrug administrationRadiological healthInternational medical device regulators forumAmerican association for cancer researchOncology centerPatient focused drug developmentOffice of new drugsChief medical officerDeputy directorNew drugsDrug evaluationClinical trials dayInternational council

FDA Roundup: May 21, 2024

FDA Roundup: May 21, 2024
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Hilary marstonRobert califfKevin buginOncology centerOffice of digital transformationUdall foundationRadiological healthOffice of new drugsOffice of media affairsDrug administrationEquity programOnline controlled substances summitReagan udall foundationConditionally approved new animalClinical trial innovationChief medical officer

Greater FDA Oversight of Laboratory-Developed Tests: A Needed Change?

Greater FDA Oversight of Laboratory-Developed Tests: A Needed Change?
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United statesAnn arborCara tenenbaumDanielf hayesUniversity of michiganRadiological healthStrathmore health strategy in kensingtonDrug administrationAmerican society of clinical oncologyFriends of cancer researchFederal foodAmerican societyClinical oncologyStrathmore health strategyCancer research

Karius Test® Receives FDA Breakthrough Device Designation to Aid in the Diagnosis of Infectious Disease – IT Business Net

Karius Test® Receives FDA Breakthrough Device Designation to Aid in the Diagnosis of Infectious Disease – IT Business Net
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United statesNormane sharplessBrad perkinsDrug administrationAnnals of the american thoracic societyAmerican thoracic societyBreakthrough devices programNational cancer instituteKarius incLaboratory developed testAmerican thoracic society annual meetingInternational conferenceRadiological healthKarius testBreakthrough deviceChief medical officer

What You Should Know About The FDA s New Final Rule On LDTs

What You Should Know About The FDA s New Final Rule On LDTs
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New yorkUnited statesPhilipr desjardinsPhilip desjardinsJohnson medtechArnold porter biosliceMahnu davarMahnuv davarPhillipv defedeleAbeba habtemariamPhillip defedeleDrug administrationRadiological healthUs public health serviceYork state clinical laboratory evaluation programResearch use only investigational