• If you fail to plan, plan to fail

    We’ve all heard this saying, right? Sometimes though, it takes a fail in our lives for us to remember it again and let it sink in! This time of year many of us are getting [...]

  • A changing perspective

    Perspective…we all have one, but have you ever had an experience that made you change your perspective? I recently had one of those moments at the 2017 Parenteral Drug Association (PDA) Annual Meeting I attended in May. [...]

  • Why Is There a Divide Between Scientists and Engineers?

    Few disciplines are as closely related as science and engineering yet a huge divide exists between the two. Close collaboration between scientists and engineers is required in the development of combination products. Bridging the divide between the [...]

  • The Facts About Combination Product Regulation and Risk Management

    Combination products offer novel or improved treatment options, but can present significant regulatory and risk management challenges. Because these products incorporate two or more regulated components, the ability to achieve regulatory compliance and managing compliance [...]

  • How to Determine a Combination Product’s Primary Mode of Action

    Combination products raise distinct regulatory challenges because they comprise two or more regulated components. Depending on its constituent parts, your combination product may require a review by several agency centers at the U.S. Food and [...]

  • Will the FDA’s Intercenter Pilot Project Improve the Combination Product Submission Review Process?

    Combination products present regulatory challenges because their constituent parts must be reviewed by more than one agency center. Under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act, combination products are assigned to a lead center based on their primary [...]