FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics

2020-04-21T17:02:39-04:00

The Food and Drug Administration recently published final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products,” in which the FDA lists several key considerations for companion diagnostic manufacturers.

FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics2020-04-21T17:02:39-04:00

The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?

2020-04-06T15:19:56-04:00

At its core, the VALID Act would explicitly grant the FDA authority to regulate LDTs through a risk-based framework that categorizes LDTs as high risk or low risk, with high-risk tests facing approval requirements that are comparable to existing medical device regulations.

The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?2020-04-06T15:19:56-04:00