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  • Is Human Factors Testing a Good Idea for Your Combination Product?

    Effective management of use-related risks is crucial to ensuring the safety of your combination products. In the past, labeling and training were justifiable strategies for reducing use-related risks. […]

  • 6 Steps to 21 CFR Part 4 Compliance for Your Combination Product

    Combination products, made up of two or more components, have skyrocketed in the healthcare industry in recent years; however, complying with evolving legislation can be a nightmare for manufacturers. […]

  • Does Your Existing Combination Product Need Design History Files?

    Combination products are defined by the U.S. Food and Drug Administration as products that are some combination of drugs, biological products and/or devices. For instance, a medical device packaged with the drug it administers would [...]

  • Is Your Product Truly a Combination Product?

    The last three decades have seen vast growth in the development of therapeutic and diagnostic products that are a combination of two or more components. These products, termed combination products, are a distinct category of [...]

  • Combination Products: Can Partnerships Between Drug and Device Companies Streamline Efficiencies?

    The drug-device combination market is booming. On track to generate more than $115 billion by 2019, the industry is expected to overtake the growth of both the medical device and pharmaceutical sectors. Strategic partnerships between [...]

  • Obtaining a Combination Products Jurisdictional Designation

    Combination products, by their very nature, are harder for the FDA to regulate than singular products. The former can be any type of manufactured goods that falls under the specific FDA guidelines and includes some [...]

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