FDA publishes premarket guidance on combination products

The FDA has published new premarket guidance on efficient development and review of combination products, which often combine drugs or biologic medicines with a device. In a statement, the FDA referred to the technologies such as digital pills from Proteus Digital Health, which track when patients take their drugs, size of the dose, and medication is taken. The pills contain a sensor that activates when it gets wet in the stomach and sends a signal to patch that patients wear on their torso. This transmits data to an online portal that the patients can view and share with their doctor if they choose to do so.
The new premarket guidance from the FDA is designed to ensure fast and effective reviews of combination products, which can be complicated to develop while creating a robust review process to ensure they are safe and effective. In a statement FDA commissioner Scott Gottlieb said: “We’re seeing innovations that hold out great promise, but they’re increasingly blurring the lines across our medical product centers. “We believe cross-center collaboration is key to successfully advancing safe and effective combination products.”