COMBINATION PRODUCTS

The Combination Products Coalition was formed in 2003, to start breaking down those silos, and consider a more holistic vision of appropriate combination product regulation. The goal was always to achieve balance, balance between innovation and public safety, and balance among importing the historical approaches of medical devices, pharmaceuticals and biological products. The group was formed with very careful consideration of ensuring that all the different sectors of the combination product industry were represented in order to best ensure that balance. In this way, the industry as a whole could offer unified input on policy issues being considered by the newly formed Office of Combination Products and FDA... Over the years the coalition grew to the point where it started to include certain special areas of focus, particularly with regard to injector systems and companion diagnostics. Today the coalition maintains its laser like focus on combination products, but works with many..

Primary location: Washington United States