With products ranging in scope and complexity, implementing even a streamline regulatory framework may be challenging.
By Laura O’Brien, Ph.D., Boehringer Ingelheim Pharmaceuticals, Inc.; Nina Cauchon, Ph.D., R.A.C., Amgen Inc.; Willy Liou, M.S., R.A.C., Amgen Inc.; Tushar Mukherjee, Ph.D., Sandoz Inc.; and Satish Singh, Ph.D., Pfizer Inc.
We all probably know somebody who uses a drug-device combination product, whether it is insulin in a pen-injector, an inhaled drug for asthma, or a liquid antibiotic given to a child in a spoon. The device part of the combination product may measure the dose and/or deliver it.
Current best practice for sponsors is an integrated, systematic approach to the development and manufacture of safe and effective drug-device combination products. A combination product should be intuitive to the end-user (patient or caregiver), deliver the right dose with the right quality, and have low risk of use errors causing over/under dosing or injury.
In the U.S., regulation of combination products was historically complex due to the involvement of more than one Food and Drug Administration (FDA) center (Center for Drug Evaluation and Research [CDER], Center for Biologics Evaluation and Research [CBER], Center for Devices and Radiological Health [CDRH]), sometimes resulting in unclear requirements or inconsistent implementation.