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regulatory guidance

The findings run counter to historical data and may provide fodder to reconsider current guideline recommendations on surveillance of colorectal cancer patients.

The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.

MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.

The group of regulatory authorities from around the world has proposed a new guidance for harmonizing the procedures for assessing medical devices, including IVDs.

The FDA's draft document noted that it is providing additional clarity to help itself and manufacturers better apply the concepts in a 2003 guidance document.

While stakeholders hope that the country will continue to accept the CE-IVD mark after Brexit, the issue is unresolved, leaving firms in the dark as to what the future may bring.

Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.

The updated guidance comes on the heels of new data suggesting that for some individuals, antibodies to the Zika virus may stay in the body for months after infection. 

A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.

Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.

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