Risk Reviews Needed For Targeted-Therapeutic Investigational IVDs, FDA Says
In many cases, investigational in vitro diagnostic devices used for targeted therapeutic product studies must undergo their own independent US FDA review, separate from the drug being studied, the agency warns in a draft guidance document on investigational IVDs.
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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for a separate submission to the device center – unless the diagnostic is determined to be a serious risk, FDA says in draft guidance.
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But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic cancer therapies are not always equally effective.