- Language: English
- 104 Pages
- Published: December 2009
- Region: United States
Supplement 29 - Pharmaceutical and Medical Device Combination Products
- Published: January 2011
- Region: Global
- Euromed Communications
Combination products represent an increasingly important area of pharmaceutical development. It is estimated that almost 30% of the pharmaceutical industry research and development spend is currently allocated to such products. These combinations may include drug/device, device/drug and companion diagnostics. Only 15 years ago the term combination product would have automatically referred to a combination of two or more pharmaceutical substances. Today the term is widely understood to refer to the new type of combination of a medical device and a pharmaceutical.
For those working in clinical development, it is important to understand the approach and the different regulatory regimes that influence the development of such entities.
David Jeffreys, senior vice president of Eisai Europe