Explore the definition of combination products, their types, and real-world examples. Learn how these innovative healthcare solutions transform treatment and patient care.
What is a Combination Product? The Concoction of Drugs and Devices
In the rapidly changing world of healthcare, innovation does not stop. With advancements in medical science, we can lay hands on innovative products which help physicians design a preventative and treatment regimen simultaneously from various disciplines of medicine. The combination product, a form of innovation not new to pharma and biotech, has been among those to make waves recently. Unifying the characteristics and functionalities of drugs, devices and biological products, combination products have transformed how we conduct diagnosis, treatment and patient care.
Combination Products: Definition, Types, and Examples
1. Defining Combination Products
The U.S. Food and Drug Administration (FDA), a leading US healthcare regulatory body says combination product refers to “a product be composed of any combination of a drug/device, biologics/device or drug/biologics/device”.
To clarify deeper, these are the 4 main categories upon which a product can be assigned as a combination product by FDA:
This category of combination product has two or more regulated components (i.e. a drug/device, biologic/device, drug/biologic or a drug/device/biologic). This mixture can be a physical combination, chemical combination or other way to comprise single entity. In other words, they stick together and become an indivisible product. One example of this is a monoclonal antibody linked to a therapeutic drug.
2. Co-packaged combination products
WHAT ARE CO-PACKAGED COMBINATION PRODUCTS? These packages may hold mixtures of drug and device products, biological and device products, or biological and drug products. So, for example a vial of drug or vaccine is this together with a delivery device.
3. Cross-Labeled Kit Product
This category is used when packaging a drug, device, or biological product and one with an approved individually specified drug, device, or biological product. The use, indication or effect of the intended product is not achievable without both products. If approved, the approval of that product is likely to require a changes in labeling for all of the products whose labeling will need to describe that new combination. One such model is a photosensitizing drug and an activating laser/light source.
4. Cross-Labeled Co-Packaged Product:
Same as the previous category, these are combination products that consist of an FDA approved or licensed individual investigational drug, device, or biological product packaged separately but intended for use only with another individually specified investigational drug, device or biological product. Both will be required to realize the desired use, indication or effect.
Real-World Examples
In order to understand the importance of combination products, let us explore a few examples from the real world that can help you categorize it better.
Single-entity combination products:
Drug-Eluting Stent: A stent coated with a drug that is used to open blocked arteries and includes special medicine or chemicals.
Transdermal Patch: A drug delivery system that delivers a controlled dosage of the drug, over time, through the skin.
Prefilled drug delivery systems: Injection and insulin injector pens filled with medication to administer drugs easily
Co-Packaged Drug Products
First-Aid Kits: These kits include several tools such as bandages, gauze and medicines like antibiotic ointments and pain relievers
Surgical Trays: Surgical trays may include surgical instruments, drapes and anesthetic/antimicrobial swabs.
Combination Products with Cross Labeling
A photodynamic therapy drug and laser/light source: These products are usually sold separately, but the label makes clear that they are intended to be used together as part of a treatment.
Conclusion
Combination products are a transformative advancement in healthcare and seamlessly bring drugs, devices and biological products together to create robust solutions for patients. These multidimensional products open new horizons for treatment, diagnosis and care thereby steering the healthcare industry towards achieving their objective of patient betterment and enhancing quality of life. With the progression of technology and our knowledge base around medicine, we can expect to see this space continue to grow and be a bit different than today.
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