Infusion Drug Delivery Articles

  1. GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products 3/2/2026

    In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions. 

  2. Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions 3/2/2026

    In this article, Chief Editor Tom von Gunden considers the need for and benefit of conducting AI-based research into regulatory precedents for drug delivery submissions and approvals. He consults combination products consultant Doug Mead on best practices in bolstering regulatory intelligence and regulatory approval success by way of advanced search methods. 

  3. Benchmarking RNA Delivery Performance: Toward Standardized Metrics For Translational Success 2/24/2026

    As RNA pipelines mature, delivery success demands shared benchmarks. This article proposes standardized, stage-specific metrics to compare platforms, guide optimization, and strengthen regulatory confidence.

  4. Advances In Endometrial-Targeted Drug Delivery In Women's Health 2/19/2026

    Johns Hopkins investigators discuss gaps in women’s health research and how their work addresses endometrial dysfunction and infertility through precision nanomedicine.

  5. 4 Opportunities For Advancing Drug Delivery 2/3/2026

    In this article, Fran DeGrazio identifies four prime opportunities for drug delivery developers to move the dial of innovation into 2026 and beyond. These avenues for advancement include diagnostics, patient tolerability, microdosing, and analytical methodologies. 

  6. The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs 1/15/2026

    The cell therapy sector is experiencing a paradigm shift in manufacturing: from bioreactor (ex vivo) to body (in vivo).

  7. Nanotechnology Drug Delivery: A Market Overview 1/6/2026

    New market research reveals the scientific, geopolitical, and business trends driving growth in the nanotechnology drug delivery market.

  8. Combination: The Drug Delivery Word Of The Year For 2026 12/30/2025

    In this article, Chief Editor Tom von Gunden explains why he sees 2026 as the year combination products and therapies become fully central to drug and biologics product development, delivery, and regulatory. He points to personalized medicine and patient self-administration as key factors shaping his view of the drug delivery landscape.

  9. Regulating For Patient Safety And Success With Combination Products 12/16/2025

    At the AFDO/RAPS Combination Products Summit 2025, a notable focus emerged around approaches to risk assessment and human factors studies. In this article, Chief Editor Tom von Gunden offers his appreciation for the biopharma industry’s consideration of patient usability and safety in the development and regulation of combination products and other drug delivery devices. 

  10. Strained Manufacturing, Complexity Stymie In Vivo Progress 12/4/2025

     Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.