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.
An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.
Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.