Injectable Drug Delivery Articles

  1. Human Factors: A Key Factor In Regulatory Approvals 5/5/2026

    In this article, combination product consultant Doug Mead demonstrates the practice and results of using GenAI search tools to conduct precedent research on Human Factors (HF) regulatory considerations. He illuminates query responses related to Complete Response Letters (CRLs), HF study waivers, use errors, critical tasks, and other aspects of FDA approvals for combination products and other delivery devices.

  2. Regulatory Attention To Human Factors: How Much Is There? 5/5/2026

    In this article, Chief Editor Tom von Gunden considers trends in drug delivery likely to drive increased scrutiny around Human Factors {HF) in regulatory submissions and approvals. In an embedded video and transcript from Tom’s conversation with combination products consultant Doug Mead, the two discuss findings from GenAI queries that surfaced FDA precedents on HF-related matters including critical tasks, use errors, and risk mitigation.  

  3. Gaining An Edge In GLP-1 Production 5/5/2026

    The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.

  4. Where Drug Delivery Falls Short And What The Industry Should Do Next 4/24/2026

    Next-generation drug delivery pairs science with usability, solving adherence by simplifying treatment, aligning patient behavior, and improving poorly tolerated therapies.

  5. Patient-Centric Drug Delivery: Do Possible And Preferable Always Align? 4/22/2026

    In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.

  6. Expanding The IV → SC Framework: What Reformulation Really Means 4/22/2026

    IV → SC is a system design challenge. Success depends on aligning formulation, device, manufacturing, and clinical strategy early to avoid costly failures and redesigns.

  7. Advances In Precision Delivery In CNS Oncology 4/13/2026

    Plus Therapeutics’ approach combines localized radiotherapy with advanced diagnostics and monitoring to improve outcomes for patients with CNS cancers.

  8. Drug-Device Combination Products: 4 Evolving Platforms For 2026 4/10/2026

    Biologic advantage won’t come from better biology alone, but from delivery technology and designing the full experience around patients, providers, and supply chains.

  9. A Case Study: Control Strategies For A Multi-Dose Pen Injector 4/8/2026

    A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.

  10. Control Strategies For Injectable Drug Delivery Combination Products 4/7/2026

    Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.