Ocular Drug Delivery Articles

1. Drug Delivery Innovation: Getting Advanced Therapies To Patients 11/3/2025

   In this article, Fran DeGrazio recounts the evolution of drug delivery technologies as she underscores the need to innovate in the delivery of advanced therapies. Considering chronic diseases, rare diseases, and difficult-to-reach therapeutic targets, Fran offers suggestions for organizing and readying for the development and delivery of platforms, systems, and devices for next generation treatments, including personalized, precision medicines.

2. 7 Management Strategies For Combination Product Regulatory Success 9/2/2025

   In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success. 

3. Understanding Annex 1 For Sterile Medicinal Products 8/4/2025

   In this article, Fran DeGrazio outlines concepts from the EU Annex 1 guidance for sterile medicinal products. She highlights key considerations for the manufacturing of sterile products and offers recommendations for contamination control, facilities upgrades, quality risk management, testing, inspections, and personnel training. 

4. Drug Delivery Innovation: If You Build It, Will Anyone Care? 7/1/2025

   In this article, Fran DeGrazio explains why innovation in drug delivery technologies may not need to be revolutionary, but will no doubt need patient adoption, payor support, and regulatory follow-on to become sticky in the marketplace. 

5. 3 Lesser Known Keys To Effective Biopharma Supplier Engagement 6/4/2025

   In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services. 

6. 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.

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. 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. 

9. 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.

10. Understanding Essential Drug Delivery Outputs: Things To Know About EDDOs 11/5/2024

    The FDA draft guidance on Essential Drug Delivery Outputs (EDDOs) stirred interest from industry in how best to respond. In this article, Fran DeGrazio summarizes and comments on key clarifications and recommendations that emerged in a Drug Delivery Live! online event on the topic, which she moderated.