Inhalation Drug Delivery Articles

1. 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.

2. 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.

3. 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.

4. 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. 

5. Human Factors: A Key Factor In Regulatory Approvals 5/5/2026

   In this article, combination product consultant Doug Mead demonstrates the practice and results of using GenAI search tools to conduct precedent research on Human Factors (HF) regulatory considerations. He illuminates query responses related to Complete Response Letters (CRLs), HF study waivers, use errors, critical tasks, and other aspects of FDA approvals for combination products and other delivery devices.

6. Regulatory Attention To Human Factors: How Much Is There? 5/5/2026

   In this article, Chief Editor Tom von Gunden considers trends in drug delivery likely to drive increased scrutiny around Human Factors {HF) in regulatory submissions and approvals. In an embedded video and transcript from Tom’s conversation with combination products consultant Doug Mead, the two discuss findings from GenAI queries that surfaced FDA precedents on HF-related matters including critical tasks, use errors, and risk mitigation.  

7. Patient-Centric Drug Delivery: Do Possible And Preferable Always Align? 4/22/2026

   In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.

8. Minding The Gap: Submission Strategies For Combined Use Combination Products 4/17/2026

   For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.

9. Does TSLP Inhibition Signal The Next Wave Of Respiratory Biologics? 4/1/2026

   Thymic stromal lymphopoietin (TSLP) inhibition has firmly established itself as a strategy in respiratory disease. This article highlights some promising drug candidates and next-generation approaches.

10. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.