Inhalation Drug Delivery Articles

1. 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.

2. 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.  

3. 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.

4. 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.

5. 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.

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   A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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

7. GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products 3/2/2026

   In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions. 

8. Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions 3/2/2026

   In this article, Chief Editor Tom von Gunden considers the need for and benefit of conducting AI-based research into regulatory precedents for drug delivery submissions and approvals. He consults combination products consultant Doug Mead on best practices in bolstering regulatory intelligence and regulatory approval success by way of advanced search methods. 

9. Overcoming Lung Tumor Barriers: Nanoparticle Delivery Strategies For Pulmonary Cancers 2/20/2026

   Solid lung tumors have a complex tumor microenvironment that creates barriers to drug delivery. Nanoparticle therapies can overcome these challenges.

10. 4 Opportunities For Advancing Drug Delivery 2/3/2026

    In this article, Fran DeGrazio identifies four prime opportunities for drug delivery developers to move the dial of innovation into 2026 and beyond. These avenues for advancement include diagnostics, patient tolerability, microdosing, and analytical methodologies.