What is a combination product?
Combination products are defined in 21 CFR 3.2 (e). The term combination product includes: A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
What are licensed products and combination products?
Combination Product means a product that contains a Licensed Product component and at least one other essential functional component. If LICENSEE sells a Licensed Product or Combination Product in the US, LICENSEE shall manufacture said product substantially in the US.
What is the difference between a combination product and a biologic?
All 3 articles are combined in a single product (e.g., a prefilled syringe containing an antibody-drug conjugate), device to manufacture a biologic also includes a drug or biologic in the kit, or the product contains two different combination product types (e.g., Type 1 and Type 2 are provided together
Is a package that contains only devices a combination product?
A package that contains only devices is not a combination product. Additionally, a product that is a combination of only drugs is not a combination product.
Combination product. Combination product may refer to : Combination drug, two or more drugs formulated together combination product (medical), The US FDA term for a medical device and the drug or biologic it is intended to deliver.
What is a combination drug product?
Combination products are products that combine two or more different types of FDA-regulated products, including drugs, biologics, and medical devices. Regulators are working to make this process easier with the establishment of the Combination Product Council, identifying process improvements, and facilitating communication between agency centers.
What is fixed drug combination?
A combination drug is a fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.