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   The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential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

5. 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?

6. 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.

7. 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.

8. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

   ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

9. How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies? 12/5/2024

   FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.

10. 5 Top-Of-Mind Drug Delivery Topics In 2024 12/3/2024

    In this article, Fran DeGrazio highlights five drug delivery challenges that were commonly discussed by industry insiders throughout 2024. With particular focus on combination products, these key themes included supplier qualification, cross-functional product development, platform approaches, patient self-administration, and regulatory considerations.