Featured Editorial

1. 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.

2. 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.

3. The Hidden Operational Complexities Of Home Infusion 5/20/2026

   Home infusion can lower costs and improve access, but requires complex coordination, patient readiness, logistics, and monitoring to ensure safe and effective care.

4. Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease 5/19/2026

   Autologous intradiscal therapy integrates delivery and biology into one system, highlighting the potential of cell therapies in complex, localized disease environments.

5. Surgical Therapeutic Design: Key Considerations In Formulation And Delivery 5/18/2026

   Conventional antibiotic prophylaxis often fails to maintain therapeutic levels at the surgical site over time; controlled-release local antibiotics can solve this.

6. Need A Drug Delivery Conversation Starter? Try Target Product Profile 5/18/2026

   In this article, Chief Editor Tom von Gunden explores the need for and existence of cross-functional communication during drug product development and delivery device selection. He consults industry veterans with experience in various formulation or delivery roles at GSK and Merck. They identify the Target Product Profile (TPP) as the core concept guiding collaboration. 

7. When Software Becomes Part Of The Medicine 5/15/2026

   Software is no longer just a support tool; it is central to real-world efficacy, transforming combination products by optimizing dosing, adherence, and technique.

8. Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery 5/14/2026

   Cell therapy success depends on a durable implantation environment, making delivery and sustainability central to efficacy and functional outcomes.

9. Treatment Adherence And Designing Therapeutics To Meet Patient Needs 5/6/2026

   Reformulation improves adherence by reducing pill burden and side effects, enhancing real-world usability and align therapies with diverse patient needs.

10. Complaints Into Practical Action: Human Factors Drug Delivery 5/5/2026

    Post-market HF are more than a quality metric, they help teams diagnose issues, guide fixes, and improve real-world usability of drug-device products beyond validation.