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.
The bill has received bipartisan support for removing barriers and accelerating innovation in medical devices, drugs and biologics.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.