Drug-device combination products: Device regulatory submission content and considerations
RF QuarterlyChin-Wei Soo, DrSc, FRAPS • Niedre Heckman, PhD, MPH, FRAPS
Combination products/companion diagnosticsEuropeUnited StatesRF QuarterlyChin-Wei Soo, DrSc, FRAPS • Niedre Heckman, PhD, MPH, FRAPSCombination products/companion diagnosticsEuropeUnited States