Clinical Supply Regulatory Articles

1. The NDC-12 Ripple Effect: Why Clinical Trial Supply Chains Must Act Seven Years Early 3/30/2026

   Clinical trial supply chains face a 2033 NDC-12 deadline; early action on product identity, labeling, and data governance can prevent costly disruptions and misalignment.

2. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

   The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

3. 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.

4. What Global Survey Says About Scant Patient Access To CAR-T Therapy 6/17/2025

   The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.

5. When Shipments Stop: Understanding And Managing Customs Delays In Clinical Supply Chains 4/15/2026

   Customs delays aren’t random disruptions. They reveal where documentation, classification, and context fail to align under scrutiny across complex global trials.

6. Why Good Data Still Fails: Inconsistency, Visibility, And Decision Risk 4/22/2026

   Even with strong visibility clinical supply chains face delays when data is inconsistent across systems. Alignment not more data drives faster, clearer border decisions.

7. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

8. Tariffs Threaten Clinical Trial Supply Chains: Preparing For Volatility 2/10/2026

   Tariffs and FDA staffing gaps are quietly reshaping clinical trial supply chains. From comparators to customs delays, these forces are creating real risk for timelines, budgets, and patients.

9. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

   How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

10. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

    The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.