According to the FDA, a combination product is the combination of a drug and a device. It can include two or more dependent products either packaged together or separately. An example would be an insulin injector pen which diabetic patients use to control their glucose levels.

Based on our lecture or online articles what are the necessary regulations to get FDA approval of a combination product? Also determine the necessary steps if the lead agency of the combination product was :
a. CDER: Center for Drug Evaluation & Research
b. CBER: Center for Biologics Evaluation & Research
c. CDRH: Center for Devices & Radiological Health