The Unique And Complex World Of Combination Products

Combination products present distinct benefits by offering improved therapeutic outcomes or increased patient convenience. Generally, they encompass drug-device or biologic-device combinations. The regulatory pathway for approval, determined by the primary mode of action, dictates which FDA center has jurisdiction. Tune in to the podcast for deeper insights into combination products and their regulatory framework.

Speaker Bio: John Lockwood is Senior Director, Head of Medical Devices/IVDs, Americas for PharmaLex, where he leverages his more than 28 years of industry experience across quality, regulatory, operations, development, validation, and purchasing. John has worked at both small and large medical device manufacturers and has spent more than a decade in consulting.