INHALATION DRUG DELIVERY ARTICLES

GettyImages-2158404004-auto-injector-medicine Delivery Device Functional Scrutiny: Can You Pass (Without) The Test?

In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).  

INHALATION DRUG DELIVERY VIDEOS

Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.

What constitutes an EDDO (Essential Drug Delivery Output)? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC illustrates how to identify system-level drug delivery outputs that are device-dependent and, therefore, essential. 

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 Barr Weiner to describe the role of case study examples in defining and regulating combination products globally. Weiner makes the case for agreement about the science and technology being more important than commonality in terminology, Panelist Fran DeGrazio agrees.

In this initial episode of The Combination Products Handbook: The Series, a chapter-by chapter videocast series introducing topics from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023), host Tom von Gunden discusses the book’s intent with its editor, Susan Neadle. The discussion focuses on the rationale for each chapter and the expert contributions of various chapter authors and co-authors.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • Advanced nanotechnology improves biologics with higher drug loads, better stability, new delivery routes, and enhanced performance in injectables, inhalation, and long‑acting therapies.

  • Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.

  • An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.

  • Weiler Engineering’s ASEP-TECH® Blow/Fill/Seal machines are ideal for processing temperature sensitive products such as biological and protein-based materials – providing a level of enhanced sterility assurance.

  • Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.

  • See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.

  • Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  • Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).

  • How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.

  • Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.