Hogan Lovells LLP
Hogan Lovells’ food, drug, medical device, and agriculture practice group consists of technically trained lawyers, consultants, and scientists with experience in the field of in vitro diagnostic (IVD) products, including companion diagnostics used with pharmaceutical products. Our diverse professional staff offers both legal and regulatory services to pharmaceutical, life sciences, biological, and medical device/diagnostic manufacturers and healthcare service providers. We assist clients in obtaining market approvals and clearances for diagnostic tests, as well as related instruments and software that are regulated by the U.S. Food and Drug Administration (FDA). We also advise clients on pharmacogenomics, biomarkers, surrogate endpoints, toxicogenomics, as well as on similar initiatives in the EU. Current trends in lifecycle management involving pharmacogenomic labeling are also explored. The food, drug, medical device, and agriculture practice group based in the United States regularly works with lawyers and other consultants in our Brussels and other EU offices to better serve clients worldwide.