Inhalation Drug Delivery Articles

  1. Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations 9/1/2026

    In this article, consultant Doug Mead reports on precedent research he conducted into FDA databases on 21 CFR Subpart cGMPs for combination products. His observations and conclusions offer sound advice on how to approach summaries submitted for BLA and NDA purposes. 

  2. Turning A Historically Limited Modality Into A Respiratory Drug Opportunity 8/26/2026

    How can sponsors revive a promising modality with known safety limits? Vast Therapeutics CEO Nate Stasko, Ph.D., explains how ALX1 is reshaping nitric oxide delivery.

  3. Inquiries In Inhalation, Part 2: Having A Nose For Innovation 8/19/2026

    In this follow-up article, Chief Editor Tom von Gunden extends his Part 1 discussion of therapeutic targets for inhaled drugs and biologics into specific aspects of delivery innovation. Among the key considerations are particle engineering, device usability, and the coordination across the ecosystem of inhalation delivery design, development, and distribution. The coverage of advances in device technologies includes inhalers, nebulizers, and nasal sprays. 

  4. Inquiries In Inhalation, Part 1: The Breadth Of Breath 8/12/2026

    In this article, Chief Editor Tom von Gunden considers the expanding range of addressable targets for inhalation drug and biologics delivery. He reports on innovations in oral and nasal inhalation technology that enhance approaches to traditional respiratory indications, as well enable delivery of inhaled therapies to systemic targets beyond the nose and lungs.

  5. Delivery Device Functional Scrutiny: Can You Pass (Without) The Test? 7/13/2026

    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).  

  6. Stability And Release Testing For Delivery Devices: Waived Or Wanted? 7/13/2026

    In this article, combination product consultant Doug Mead reports on precedent research he conducted on requests for FDA waivers on functional stability and release testing for drug delivery devices. He provides sample scenarios in the context of device design considerations for Essential Performance Requirements (EPRs) and the more recent FDA draft guidance on Essential Drug Delivery Outputs (EDDOs).

  7. Improving Execution Of Biological Evaluation Of Drug Delivery Devices 6/3/2026

    This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.

  8. From Exosomes To Nanodrugs: Advancing Therapeutic Delivery For CNS Repair 6/1/2026

    Exosomes are biological vesicles used for cellular communication that can overcome CNS barriers, delivering therapeutic cargo for CNS and optic nerve injuries.

  9. Risk Is the Spine: What The First 100 QMSR Inspections Reveal 5/29/2026

    The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

  10. Need A Drug Delivery Conversation Starter? Try Target Product Profile 5/18/2026

    In this article, Chief Editor Tom von Gunden explores the need for and existence of cross-functional communication during drug product development and delivery device selection. He consults industry veterans with experience in various formulation or delivery roles at GSK and Merck. They identify the Target Product Profile (TPP) as the core concept guiding collaboration.