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  • Can the FDA keep pace with the science behind drugs and medical devices?

    Understanding the science behind drug, biological and medical devices ensures that combination products are safe for the market. The Food and Drug Administration (FDA) needs to collaborate with the Center for Drug Evaluation and Research, [...]

  • How to Determine the Right Regulatory Path for Combination Products

    Recent FDA reforms — such as the federal agency’s lean management model and new Combination Products Policy Council — plan to simplify combination product review. However, getting a medical device to market is still a [...]

  • Will the FDA’s New Combination Products Policy Council Help with Key Decision-Making for Combination Products?

    In March, the FDA spearheaded a lean management model that will transform the combination product review process. Now, the federal agency has introduced a new committee that will address industry policy issues, a change that [...]

  • Will FDA Changes Lead to a Better Combination Products Review System?

    You need to decipher ever-complex guidelines and a labyrinth of legislation before you can get a combination product to market. Correct product labeling and training is no longer enough; your company requires comprehensive workflows to [...]

  • 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. […]

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