Inhalation Drug Delivery Videos

  1. Understanding the Difference Between EDDOs and Primary Functions 10/9/2024

    How do Essential Drug Delivery Outputs (EDDOs) differ from Primary Functions – for example, as described in ISO 11608 regarding needle-based injection systems? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, describes the differences between the two concepts, including how they differently relate to considerations of risk.

  2. Global Harmonization Of Combination Products Regulatory 1/12/2026

    In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on regulatory movements of note. From his combination products and global operations leadership roles at FDA and now as regulatory consultant, panelist Barr Weiner points to global harmonization of regulatory definitions and requirements. Panelists Rumi Young and Fran DeGrazio weigh in on stability testing and specific ICH, ISO, and AAMI standards.

  3. Integrating Development Processes For Combination Products 1/27/2025

    The discussion highlights key aspects of a biopharma organization’s business and operations that must be effectively integrated when developing drugs and devices in tandem. These include imperatives such as establishing common terminology, applying QbD (Quaility by Design) principles, and managing supplier controls for providers of constituent parts.

  4. Preconditioning Devices under EDDO Guidance 10/9/2024

    What does the FDA’s guidance on Essential Drug Delivery Outputs (EDDOs) mean for activities involved in preconditioning the device delivery components of combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, discusses the likely intent and impact of EDDOs on preconditioning for both manufacturers and sponsor companies.

  5. Next Generation Drug And Biologics Delivery Technologies 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, host Fran DeGrazio asks panelists James Wabby of biopharmaceutical company AbbVie and Carolyn Dorgan and Courtney Evans of device consultancy Suttons Creek to comment on trends and advances they anticipate in the next phase of delivery development. Those include combination therapies, nanotechnology, reconstitution, and microfluidics.

  6. Understanding CGMPs For Combination Products 1/15/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 4 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems with the book’s editor, Susan Neadle, and chapter co-author Mike Wallenstein. In the exchange, Susan and Mike share their perspectives on combination product CGMP’s, including regulatory definitions and differences in the U.S. and Europe, supplier controls, design controls, and manufacturer responsibilities.

  7. Considering Human Factors In Combination Product Design And Use 3/7/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 7 on human factors engineering (HFE) from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the chapter’s co-authors.

  8. Developing Regulatory Strategies For Combination Products 12/16/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.

  9. Regulating Drug Delivery Platform And System Development 1/12/2026

    In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks panelist Fran DeGrazio to comment on her front-of-mind topic of systems thinking and platform approaches to combination product development.

  10. Drug Delivery Technology Adoption: A Case Of Too Many Options? 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, uses the case of Enbrel® and the multiple delivery options for it to illustrate patient considerations and market factors that can impact product success.