FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics

21 December 2018

New draft guidance for the labeling of drug and diagnostic products released earlier this month by the Food and Drug Administration (FDA) aims to expand the labeling of a companion diagnostic (CDx) across a specific group or class of therapeutics, rather than a specific drug, as is current practice.

The guidance, entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” is part of a broader agency focus on personalized medicine.

Central to the guidance is the consideration of when broader labeling of a CDx would be appropriate. Oncology companion diagnostics with broader evidence-based indications will facilitate optimal access to testing, promoting better patient care.

The FDA is accepting public comments on the guidance, due by February 5, 2019.

Our CEO and President, Joe Ferrara outlines the oncology CDx landscape and key considerations for developing a CDx commercialization strategy in a presentation given in Berlin earlier this month.

To learn more about the FDA’s new draft guidance and implications for innovators please contact us.

Boston Healthcare has been successfully advising both emerging and established diagnostics companies on how best to commercialize their products for 25 years.

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China set to relax regulations for medical device and IVD products

On June 25, 2018, the Chinese Ministry of Justice announced amendments to the Supervision and Administration of Medical Devices Regulations (the Regulation) and called for public comment. The proposal is being celebrated by a variety of stakeholders across the medical device and IVD industry following years of lobbying to have the Regulation amended. However, some apprehension regarding the implementation of the proposed Regulation remains. Download the PDF