Transdermal 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. 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. 

3. 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.

4. Subcutaneous Self-Administration: 3 Key Market Drivers, 3 Key Delivery Challenges 3/4/2025

   In this article, Fran DeGrazio comments on the potential for subcutaneous delivery of drugs and biologics to advance and ease approaches to patient self-administration. Among the drivers and challenges she identifies are geriatric populations, chronic conditions, complex formulations, and drug delivery device selection.

5. Growth And Advancements In Transdermal Drug Delivery 2/19/2025

   The transdermal drug delivery system industry is seeing significant growth. Let's look at new market research, including the advanced technologies being used and the therapeutic areas seeing the most impact.

6. How Automation And AI Can Accelerate Clinical Research And Outbreak Response 2/18/2025

   Explore AI-driven automation and organ-on-a-chip technology to accelerate infectious disease research, enhancing assay efficiency, and improving vaccine and therapeutic development for emerging global health threats.

7. 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   The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential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. 

8. 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?

9. 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.

10. 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.