Clinical Supply Regulatory Articles

1. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

   Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

2. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

   Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

3. 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).

4. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

   A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

5. Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making 2/27/2025

   The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

6. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

   This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

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. 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.

9. Supplying Complex, Controversial, And Intercontinental Clinical Trials 3/13/2024

   Planning a clinical supply strategy for a complicated substance, psilocybin, is tricky. It's even more tricky doing it from the other side of the planet. Here's one company's approach.

10. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

    Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.