Clinical Supply Regulatory Articles

1. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

   Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

2. Quick Takes From Takeda Austria's Annex 1 Rollout 3/25/2024

   At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.

3. 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.

4. 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.

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. FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

   This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.

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   FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

8. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

   This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

9. 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.

10. 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.