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Previous Blogs

SmartDose Gen II Drug Delivery Platform
Combination products Integrated Solutions
Combination Products: The Top Three Device Challenges

By Jen Riter

十二月 31, 2019

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.

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Mixject Admixture System
Combination products
Co-Packaged Combination Products – System vs Component

By Doug Hostetler

一月 30, 2018

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.

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