Featured Editorial

31. 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.

32. PMS And Supply Chain Visibility For EU Compliance 2/10/2025

    One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.

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    The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential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

34. mRNA Empowering Engineered In Vivo Cell Therapies 1/21/2025

    Recent advances in non-viral delivery technologies have enabled a first generation of genetically modified immune cells in vivo. Deploying these new approaches can address challenges with traditional ex vivo CAR-T cell therapy.

35. Only DTx In Drug Delivery Can Take Us To The Next Level Of Diabetes Care 1/8/2025

    The convergence of advanced technologies and advancements in drug delivery is reshaping diabetes care. Digital therapeutics (DTx) deliver therapeutic interventions driven by high-quality software and mobile applications.

36. 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?

37. 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.

38. 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. 

39. 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.

40. 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.