Ocular Drug Delivery Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 

  6. 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.

  7. 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.

  8. Eying Up The Era Of Topical Biologics 3/19/2024

    Claris Bio’s phase 1/2 clinical trial in patients with Stage 2 or 3 Neurotrophic Keratitis (NK) is breaking new ground in the development of topically administered biologic therapies. 

  9. 10 Ways To Align Your Medical Device With Human Factors Industry Best Practices 3/1/2024

    Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.

  10. New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology 3/29/2023

    Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.