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 rise in chronic disease and the effort to reduce healthcare costs presents a large opportunity for the field of regenerative medicine.
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.
In lieu of trials, some companies may be able to submit a CER.
When preparing a regulatory submission, there are a couple of critical elements to consider.
A peek at the latest miniaturization trends, including nano-robots that transport therapeutics to tumors.
As the agency continues to try to do more with fewer resources, taking additional risks is imperative to move forward.
Industry doesn’t anticipate roadblocks from the Senate, expects confirmation.