How to CE Mark a Medical Device that Incorporates a Drug
An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.
Tag Archives: combination products
What Do FDA Investigators Look for During an Inspection?
Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.
FDA: Developing Combination Products Requires Consistency, Transparency, Collaboration
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.
Five Important Facts About 21st Century Cures Act
The bill has received bipartisan support for removing barriers and accelerating innovation in medical devices, drugs and biologics.
How to Gather Clinical Evidence for Combination Products
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.
Meshing Drug and Device Manufacturers in Risk Management
Differing approaches to risk could hamper further growth of combination products.
Combination Products Progressing in Fits and Starts
The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.
Device Meet Drug: Integrating Combination Products Into Your Portfolio
Combination products are a major growth area for life science companies and in the future, many companies have or will have combination products in their portfolio. Combination products are made of drug, device and/or biologics constituent parts. Each constituent part has its own set of regulations to which it must adhere. For example, even if…
Putting the Lab in the Patient, MIT Device Assesses Best Drugs to Treat Cancer
A tiny implant developed at the Massachusetts Institute of Technology aims to take the guesswork out of which drugs work better than others when treating cancer patients.
A tiny implant developed at the Massachusetts Institute of Technology aims to take the guesswork out of which drugs work better than others when treating cancer patients.
