Clinical Supply Regulatory Articles

  1. New Initiative Seeks To Back Up ICH's Harmonization Mission 5/3/2024

    An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.

  2. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

    Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

  3. The Small Biotech's Checklist For FIH Trials 8/27/2024

    Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

  4. FDA Staffing Constraints And Operational Risk In Clinical Supply 2/11/2026

    FDA staffing shortages and supply pressures are reshaping clinical trials, requiring closer coordination across regulatory, manufacturing, and operations.

  5. Climbing The Blockchain Ladder To Optimize Clinical Supply Forecasting 4/16/2025

    Layering AI on top of blockchain technology offers a powerful way to predict kinks in the supply chain. Here's a look at where the technology is headed.

  6. New DSCSA Compliance Blueprint Includes FDA & Industry Input 4/12/2023

    Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.

  7. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

    The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

  8. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.

  9. Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

    FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

  10. Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide 10/4/2024

    ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders.