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.
What are the challenges faced by OCP?
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
Differing approaches to risk could hamper further growth of combination products.
3M Medical Materials & Technologies helps health care manufacturers design and build more reliable, innovative and feature-rich medical devices. Choose from a variety of transparent, nonwoven, or conformable double sided tapes for your medical device needs.
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…