Injectable Drug Delivery Articles

  1. 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in the context of device design considerations for Essential Performance Requirements (EPRs) and the more recent FDA draft guidance on Essential Drug Delivery Outputs (EDDOs).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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. 

  10. 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.