The FDA issued two draft guidances designed to provide clarity on the agency's recommendations for researching and developing targeted therapies. The first, titled "Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease," proposes an approach for drug developers to enroll patients based on the identification of rare mutations into clinical trials for targeted therapies when reasonable scientific evidence suggests the drug could be effective in patients with those genomic findings. The second guidance, titled "Investigational IVD Devices Used in Clinical Investigations of Therapeutics Products," seeks to provide those running clinical trials with a framework to reference when determining if an in vitro diagnostic (IVD) device used in a therapeutic product study must undergo its own FDA review, distinct from the drug being studied. The FDA also announced the availability for public comment on a draft guidance on drug and biologics products that contain nanomaterials. That guidance provides recommendations to industry engaged in developing human drug products in which a nanomaterial is present in the finished dosage form, including recommendations regarding investigational, premarket and postmarket submissions.

With the age of the companion diagnostic fast approaching, the FDA recently issued a draft guidance dealing with the use of investigational in vitro diagnostics (IVD) in drug studies, highlighting the circumstances in which the use of that IVD rises from an insignificant to a significant risk, thus incurring a regulatory liability.