Akin

Akin brings an in-depth understanding of FDA regulatory regimes to bear for clients in the pharmaceutical sector, with particular expertise in rules governing the burgeoning area of digital health, where the practice assists with the integration of AI into diagnostics and treatment planning systems. Practice head Nathan Brown brings ‘an impressive understanding of historical and current FDA enforcement and oversight approaches’ to the table, representing drug, medical devices and diagnostics developers seeking FDA clearance for new products and advising on FDA-compliant marketing strategies; he is based in Washington DC. In New York, Craig Bleifer handles issues ranging from clinical trials to product labelling, with further expertise on the FCA.