The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The enforcement operation kept nearly 500 shipments of illegal drugs and combination devices from the hands of consumers.
In order to continue to provide high quality treatment to patients, innovation must continue.
When preparing a regulatory submission, there are a couple of critical elements to consider.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.
Differing approaches to risk could hamper further growth of combination products.
This year’s work plan includes several items that will impact medical device manufacturer and suppliers.
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…