FDA Releases Draft Guidance Outlining Principles of Drug/Diagnostic Codevelopment

The US Food and Drug Administration released a draft guidance on the principles of drug and diagnostic codevelopment as a practical framework for sponsors advancing a therapeutic alongside a companion test and for agency staff reviewing these products. “Codevelopment of IVD companion diagnostics and therapeutic products is critical to the advancement of precision medicine,” the agency stated in the draft guidance. “FDA seeks to facilitate innovations in precision medicine by providing sponsors with a set of principles that may be helpful for effective codevelopment and in fulfilling FDA’s applicable regulatory requirements.” The processes for advancing a drug and test are markedly different, but the guidance provides a chart for how sponsors can align these programs and at what points they should seek input from the agency. The agency recommended that sponsors have understanding of both therapeutic and diagnostic development and both parties should be present during meetings with FDA’s drug and diagnostics divisions. Members of the public have 90 days to comment on the draft guidance.

Source: https://www.genomeweb.com/molecular-diagnostics/fda-releases-draft-guidance-outlining-principles-drugdiagnostic-codevelopment?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Molecular%20Diagnostics%20Bulletin%3A%20Accelerate%20Diagnostics%20Submits%20Pathogen%20ID%2C%20Antimicrobial%20Susceptibility%20Testing%20Platform%20to%20FDA%20%20-%2007/14/2016%2003%3A55%3A00%20PM