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US FDA’s Cancer Drug/Diagnostic Pilot Aims To Close Gap Between Regulation And Clinical Practice

 
• By Sue Sutter

Laboratory-developed tests may be misidentifying patients for treatment with targeted therapies. Under a new initiative, the FDA will work with sponsors to develop minimum performance characteristics for LDTs that may be used with an approved cancer drug in clinical practice.

Bridging Gap
The FDA wants to narrow the space between regulation and clinical practice. • Source: Shutterstock

The US Food and Drug Administration’s pilot program for oncology drugs and in vitro diagnostic tests is aimed at bringing the regulatory paradigm closer to the widespread use of laboratory-developed tests in clinical practice.

The new program also is intended to bolster patient safety by ensuring patients who receive a targeted cancer therapy actually are positive for the genetic mutation or marker at which...

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