Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.
Brian’s regulatory experience includes all types of FDA-regulated products: drugs and biologics (including animal drugs and biologics), medical devices, cannabis, foods and dietary supplements, cosmetics and tobacco products. He is a key advisor to pharmaceutical and biologic clients in the premarket, regulatory review, and marketing, enforcement and lifecycle management phases of product development. Brian works alongside his clients on drug development strategies and patent strategies across a variety of areas, including:
Pre-Investigational new drug applications (INDs), new drug applications (NDAs), orphan /specialty drug designations, biologic license applications (BLAs) and abbreviated new drug applications (ANDAs)
505(b)(2) NDAs, including new indications, dosage forms or regiments, strengths or combination products, Risk Evaluation and Mitigation Strategies (REMS), including some with elements to assure safe use (ETASU), BLAs and biosimilars (351(k) applications), Medical Devices, including 510(k) clearances and premarket approval applications (PMAs), Laboratory Developed Tests (LDTs), and combination drug/device products, Cannabis and cannabis-derived products including cannabidiol (CBD) products.