If a proposed treatment has both a drug (or biologic) and device component, the FDA may consider it a combination product.
Examples of possible combination products are asthma inhalers, drug delivery patches, collagen implants, and drug-eluting stents. The FDA may decide to treat a combination product as a drug or as a device, and that determination will affect your IRB submission.
Quorum has extensive experience with combination products. Our boards and regulatory teams understand the intricacies of combination product research. We can help determine the correct way to manage your study, and we will apply the proper standards for your product. Our support staff will ensure your study runs smoothly, and our electronic tools make communication easy.
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Contact us to learn about our expertise in combination products or to obtain a board roster, meeting schedule, or ethics review pricing.Contact Us