Some insights on integrating stability testing requirements into a device organization’s plan to make combination products.
The process gives sponsors the ability to interact more with FDA.
Start-up Ariste Medical has developed technology to reduce surgical site infections and transform implants into combination products.
The agency is creating a virtual center of excellence to expedite the development of combination products.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
Via partnerships with pharmaceutical companies, Insulet expands its platform technology past insulin delivery.
The company will invest €13 million in the facility, which will make drug-coated balloons for peripheral artery disease.
Researchers say the technology enables a high drug load and consistent drug release profile.
When preparing a regulatory submission, there are a couple of critical elements to consider.
An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.