For the better part of two decades, accompanying diagnostic devices have been developed alongside therapeutics to enable joint approvals and more efficient market penetration of therapeutic products in the United States. In that time, manufacturers of therapeutics who have wished to develop the accompanying IVD have had relatively little guidance as how to best approach the applications in a way that describes the products as complementary, rather than distinct and independent goods.
The codevelopment of these products has therefore presented manufacturers and sponsors wishing for joint market authorisation with a set of unique challenges not typically faced in the development of either one or the other. Issues exists regarding the applicability of differing regulatory requirements, the differing development schedules owing to the scrutiny of the pre-market processes for both types of goods, the potential for different sponsors for both the therapeutic good and the IVD and most crucially, the need for interaction with two different branches of the FDA; both the Center for Drug Evaluation and Research and the Center for Diagnostic and Radiological Health. The lack of FDA-issued guidance only serves to catalyse these inherent difficulties and makes the challenge of joint market authorisation near insurmountable.
That is until now. The FDA’s draft guidance, “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product”, which has been in development for almost a decade, has been issued with the intent of addressing these challenges and assisting therapeutic product and IVD device sponsors and manufacturers in the codevelopment and approval processes prior to market authorisation in the US. Specifically, the guidance details principles of development, the applicable regulatory requirements, the process of undertaking pre-market clinical trials for the therapeutic good and similar investigations of the companion IVD as well as the administrative hurdles that must be overcome for the simultaneous applications.
Of particular note is the FDA’s strong recommendation that sponsors of the therapeutics and IVDs “meet with the appropriate FDA review centers prior to launching a trial intended to advance the development of the therapeutic product and the IVD companion diagnostic” to ensure expedited market authorisations. As with all guidances, this is not a hand-holding exercise designed to tell sponsors what to do, but rather a description of the necessary endpoints that a sponsor must reach; there are various approaches for sponsors to achieve market authorisation, but the willingness and insistence of the FDA’s inclusion in the planning processes ensures that the procedures followed and data collected by the sponsor will satisfy the FDA’s requirements during the review stages of the application.
The draft guidance is just that, a draft, and the FDA have left the document open for comments and suggestions up until 13 October 2016. See the Federal Register Announcement or go directly to the regulations page to file your comments and suggestions.
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