Development, Manufacturing And Regulatory Considerations For Drug Device Combination Products
- Discussing trials and tribulations of getting complex combination products to market
- Assessing the unique challenges of dry powder manufacturing for respiratory delivery:
- Materials handling
- Moisture protection and confinement
- Manufacturing procedures
- Accurate dosing
- The second component: Blow-molding and filling the device
- Weighing the decision for manufacturing internally or externally
- Exploring the regulatory landscape and path to approval