Risk Reviews Needed For Targeted-Therapeutic Investigational IVDs, FDA Says
Executive Summary
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studies must undergo their own independent US FDA review, separate from the drug being studied, the agency warns in a draft guidance document on investigational IVDs.
You may also be interested in...
Risk Determinations For Companion Diagnostics In Oncology Streamlined By US FDA
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for a separate submission to the device center – unless the diagnostic is determined to be a serious risk, FDA says in draft guidance.
Global Medtech Guidance Tracker: December 2017
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nineteen new guidance documents were posted to the tracker since its last update.
US FDA Outlines Streamlined Development Path For Targeted Therapies
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.