Earlier this month, the FDA issued a new draft guidance to educate drug and IVD sponsors on how to develop a therapeutic simultaneously with an IVD companion diagnostic.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 issues that may come up. The guidance will also be useful for those not in the oncology field. Difficulties in simultaneously developing drugs and companion diagnostics involve logistical challenges with consulting the FDA’s drug research and diagnostic centers, as well as obtaining sponsors for both the IVD and the drug. In 2014, over 20% of new drugs and biologics were approved simultaneously with an IVD companion diagnostic, while in 2015, 28% were approved simultaneously. In the future, approximately 25% of all new drug approvals will also include approval for an IVD companion diagnostic, according to the Personalized Medicine Coalition. The FDA’s latest draft guidance is open for comments until mid-September.

Source: Regulatory Affairs Professionals Society