We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Defined under US FDA 21 CFR 3.2 (e)(2), a co-packaged combination product consists of “two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products”. (1) These device products can range from delivery devices, to bandages, to antimicrobial swabs. Understanding the regulations around such a wide range of devices can be challenging; drug companies often look to the device manufacturer/provider for guidance when filing.
In the past, often referencing a specific device registration such as a 510(k) was sufficient. Today things are different; expectations have expanded well beyond just the Design History File for a device alone. Consideration must be made for the device and drug to work as a “system.” Evaluation for functionality, compatibility and human factors must demonstrate that the device and drug work together with a successful outcome. Testing must be designed to account for the preparation and administration of a drug using all intended components and materials. This, of course, would include any primary containment system components such as vials and stoppers, and/or syringes. Testing should consider actual drug product, or drug product and diluent if a reconstitution step is required; and it should be conducted per industry standards (ISO, USP, ASTM, etc.) whenever possible. However, standards may not exist for every device/drug combination. In such a case, testing must be designed to evaluate all the critical parameters of the drug preparation and delivery process, and if possible, should be based upon, or reference, an industry standard.
Devices, now more than ever, play a critical role in many drug applications. A co-packaged combination product must be evaluated as a system, not just as individual components, and it will require testing that demonstrates successful drug delivery. As a global device developer and manufacturer, as well as contract analytical services provider, West offers the unique experience and expertise necessary for designing and executing studies to support co-packaged combination products. Contact the West Technical Customer Support team or visit the Reconstitution Systems section of our website to learn more.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.
The combination product market has seen a significant amount of growth,<sup>i</sup> driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.
One of the increasing trends in the world of drug-device combination products is the use of platforms for drug families, delivery device technologies, and primary packaging.
English
Chinese
