Injectable Drug Delivery Articles

1. Rethinking The Blueprint For Bone Regeneration: The Next Evolution In Orthobiologics 7/22/2026

   Next-generation orthobiologics could transform spinal fusion by enabling targeted bone regeneration, improving safety, and reducing reliance on traditional grafts and hardware.

2. Can We Cure Diabetes? 7/15/2026

   We caught up with Minutia CEO Katy Digovich to discuss engineered iPSC-derived islets intended for transplantation into the forearm, which could make a functional cure for insulin-dependent diabetes broadly accessible.

3. Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches 7/14/2026

   This article highlights government-funded resources available to de-risk nanomedicines, reviews principles of immunotoxicity testing, and discusses emerging methodologies.

4. Delivery Device Functional Scrutiny: Can You Pass (Without) The Test? 7/13/2026

   In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).  

5. Stability And Release Testing For Delivery Devices: Waived Or Wanted? 7/13/2026

   In this article, combination product consultant Doug Mead reports on precedent research he conducted on requests for FDA waivers on functional stability and release testing for drug delivery devices. He provides sample scenarios in the context of device design considerations for Essential Performance Requirements (EPRs) and the more recent FDA draft guidance on Essential Drug Delivery Outputs (EDDOs).

6. Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression 6/29/2026

   While circular RNA platforms can enhance protein expression, developing effective delivery strategies remains the key challenge to achieving therapeutic efficacy.

7. Navigating Combination Products: Device Complexity And Software Integration 6/4/2026

   Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.

8. Improving Execution Of Biological Evaluation Of Drug Delivery Devices 6/3/2026

   This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.

9. Risk Is the Spine: What The First 100 QMSR Inspections Reveal 5/29/2026

   The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

10. Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss 5/28/2026

    Advances in autologous stem cell and biomaterial engineering are transforming the future of regenerative medicine by enabling scalable, patient-derived therapies.