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Risk Determinations For Companion Diagnostics In Oncology Streamlined By US FDA

 
• By Sue Sutter and Sue Darcey

Information about an investigational drug and companion in vitro diagnostics may be submitted in a single investigational new drug application to the agency's drug or biologics centers, eliminating the need for a separate submission to the device center – unless the diagnostic is determined to be a serious risk, FDA says in draft guidance.

Companion Diagnostics

US FDA's newly proposed streamlined approach to risk-determination requests for oncology drug companion diagnostics should simplify the process for some sponsors now working across product centers, and also give such determinations greater therapeutic context.

However, the program's reach is limited, as spelled out in the April 12 "Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination" draft guidance

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