Inhalation Drug Delivery Articles

1. Design Controls For Drug Delivery Devices, Part 2: A Practical Perspective 5/1/2025

   In this article, Fran DeGrazio provides recommendations for implementing Design Controls in the development of combination products and other drug delivery devices. In outlining tips for drug-device product developers, Fran focuses on key considerations including risk management, chemical and functional compatibility, and regulatory compliance.

2. Smart Drug Delivery Systems: Emerging Market Trends 4/25/2025

   According to new market research, the global smart drug delivery systems market reached $12 billion in 2024 and is expected to grow at a CAGR of 17% from 2025 to 2034. Check out this article for product trends and more.

3. Design Controls For Drug Delivery Devices, Part 1: A Process Primer 4/1/2025

   In this article, Fran DeGrazio underscores the importance of design controls in the development of combination products and other drug delivery devices. She explains foundational concepts and fundamental steps including design inputs and outputs, design verification and validation, design review, and change controls. 

4. Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3 3/6/2025

   In the U.S. and the EU, there are differences in the terminology used for combination products, as well as in the format and location of the information in the dossiers. This article also proposes a harmonized approach for CTD Module 3.

5. Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression 2/18/2025

   The two most common hot water for injection (WFI) generation methods are multi-effect distillation (MED) and vapor compression (VC). There are significant differences in terms of operational principles and energy efficiency.

6. Use-Related Risk Analysis: Considering The FDA Guidance On URRA 2/5/2025

   The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential hazards in biopharmaceutical product use. In this article, Fran DeGrazio comments on the guidance in a follow-up to a Drug Delivery Live! online event she moderated on the topic of URRA. 

7. U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry 1/3/2025

   The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation. What does this mean for medical device companies?

8. 5 Reasons Why 2025 Is The Year Pharma Companies Will Revisit Their Drug Delivery Device Strategies 1/2/2025

   2025 will be the year for pharmaceutical companies to revisit their drug delivery device strategies or risk being left behind. Here are the five reasons why.

9. Drug Delivery Outlook: 7 Waves To Ride In 2025 And Beyond 12/30/2024

   With a view of the evolving landscape of health policy and patient needs, Fran DeGrazio identifies seven biopharmaceutical industry trends that should drive innovation and practical implementation in drug delivery. Harmonization, digitization, quality, intelligence, and agility are among the focus areas Fran recommends for forward-thinking biopharmaceutical companies. 

10. 9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond 12/17/2024

    Current challenges in Europe's medical device market include the EU MDR transition and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to create positive change.