Earlier this month, the FDA issued a new draft guidance to educate drug and IVD sponsors on how to develop a therapeutic simultaneously with an IVD companion diagnostic. It includes information on how to obtain marketing authorization, regulatory requirements to consider, how to plan and perform clinical trials that involve IVD companion diagnostics, and administrative […]

Late last month, Vice President Joe Biden announced additions and changes to the Cancer Moonshot Task Force initiative. These include, but is not limited to, the National Cancer Institute (NCI) collaborating with 20–30 pharmaceutical and biotechnology firms to accelerate researchers’ access to data, “investigational agents” and approved drugs, with the first agents estimated to be […]