Ocular Drug Delivery Articles

1. 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. 

2. 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.

3. 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   The FDA draft guidance on Essential Drug Delivery Outputs (EDDOs) stirred interest from industry in how best to respond.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.

4. 5 Keys to Supplier/Purchasing Controls – And Product Quality 10/1/2024

   The growth of combination products in the market, as well as new quality and regulatory standards that apply to them, are driving the increased significance of suppliers. Every drug device combination product will utilize third parties for various services, constituent parts, or other components. In this article, Fran DeGrazio lays out five foundational considerations for implementing an effective supplier/purchasing controls process.

5. Preparing For The FDA QMSR: Will You Be Ready? 9/3/2024

   The new FDA Quality Management System Regulation (QMSR) becomes effective in February 2026. In this article, Fran DeGrazio discusses the implications for combination product and medical device developers as they prepare to demonstrate QMSR compliance.

6. Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing 7/29/2024

   In Part 2 of a two-part series, Fran DeGrazio explains why best practices in particle testing and related risk-based approaches to product quality should not wait for official regulatory guidances and standards to catch up.

7. Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail 7/29/2024

   Regulatory guidance and standards, in official documentation, tend to emerge at a slower pace than do industry best practices. In Part1 of a two-part series, Fran DeGrazio explains why biopharma companies should build and apply best practices in advance of official regulations regarding drug product quality.

8. The Key to Regulatory Innovation? Global Harmonization 6/4/2024

   Innovation in drug development and delivery is often thought of as purely a technical matter. In this article, Fran DeGrazio illustrates why innovation must also be applied to regulatory practices. 

9. Ophthalmic Drug Delivery 4/11/2024

   Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.

10. Contract Design And Development Vs. In-House: How To Find The Best Fit 3/21/2024

    Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.