In vitro diagnostic assays are playing an increasingly important role in the pharmaceutical development process. The availability of companion diagnostics will be essential to securing the approval of some drugs; in other instances, FDA is requiring that diagnostic information be incorporated into drug labeling. Because of our expertise in the regulation of both diagnostics and pharmaceuticals, HPM is able to assist both IVD and pharmaceutical clients on issues relating to companion diagnostics. We can help clients develop a regulatory strategy that simultaneously addresses both the requirements for the IVD and the pharmaceutical product.
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