Combination products offer unique advantages in terms of delivering improved therapeutic outcomes or enhanced patient convenience. Typically, combination products are understood to be a drug-device or biologic-device combination. The regulatory strategy as to which center at the FDA has jurisdiction over product approval depends on their primary mode of action. Listen to the podcast to learn more about combination products and how they are regulated.
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.