Combination Products : What Are They? How Do Design A Suitable Trial?

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Combination Products: What are they? How do we design a suitable trial?
BME 5950 Special topics in BME – FDA regulation
Zhenlin Huang
Outline
I. What is the combination product?
1. Definitions of combination product
2. The major three components: drug, device, and biologics.
II. Case study: drug-eluting stent
1. History of drug-eluting stent
2. The first FDA approved drug-eluting stent
3. Review responsibility of FDA approval on the DES
4. Other further investigations
5. Discussions
III. Case study: regenerative medicine
1. Combination product in regenerative medicine
2. The first FDA approved ….
3. Review responsibility
4. Others consideration
5. Discussions
IV. Discussions and future challenges

I. What is the combination product?
1.
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The other is the combination products with other types of FDA-regulated articles, such as foods, nutraceuticals, or cosmetics called cosmeceuticals. Figure 1. Combination Product.
2. The major three components: drug, device, and biologics
FDA categorizes three classes of product: (1) Drug, (2) Device, and (3) Biologics. Drug is the product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, which is regulated by the Center for drug evaluation and research (CDER). The second category- Device is the product which does not achieve its intended purposes through chemical reaction in human, and it is not dependent upon being metabolized to achieve its primary purposes. This product is called an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar. Device is regulated by the center for devices and radiological health (CDRH), and the biologics are regulated by the center for biologics evaluation and research (CBER). For now, there is not a specific center to review the combination product.
II. Case study: Drug-eluting stent (DES)
1. History of Drug-eluting Stent
In the 1970s, coronary angioplasty was first introduced as the minimally invasive way of re-opening coronary arteries that had been narrowed by the plaque. Physicians inserted a balloon via the catheter into the peripheral artery and then inflated the balloon to compress the plaque against the artery wall. However, the
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