Clinical Supply Regulatory Articles

1. Managing Supply Chain Risk In Scale-Up And Multisite Trials 1/23/2026

   Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.

2. FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission 10/18/2024

   The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.

3. Is The BIOSECURE Act The First Real Step Toward Reshoring? 11/22/2024

   The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

4. 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.

5. FDA Publishes Final Guidance On Reporting Listed Drug Amounts 4/10/2024

   Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.

6. 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.

7. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

   The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

8. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

   FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

9. What Sponsors Must Know About Digital Systems And AI Compliance 7/17/2025

   Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.

10. 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).