Survey: Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation

Though response was limited in Dark Daily’s poll, the message from respondents was overwhelmingly negative on LDT regulation by the FDA Most respondents to a recent industry survey said that should Food and Drug Administration (FDA) approval be required in the future for laboratory developed tests (LDTs), innovation will suffer. This conclusion echoes what opponents […] The post Survey: Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation appeared first on Dark Daily.
Source: Dark Daily - Category: Laboratory Medicine Authors: Tags: Compliance, Legal, and Malpractice Laboratory News Laboratory Testing anatomic pathology CLIA clinical laboratory Clinical Laboratory Improvement Amendments Diagnostic Kit or Laboratory Developed Test FDA FDA regulation Food and Drug A Source Type: news