Clinical Supply Regulatory Articles

1. EU Reg. 536/2014's Expiry Label Requirement Forces Us Backward, Not Forward 9/14/2022

   In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.

2. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

   Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

3. 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.

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 Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

   FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical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.

5. 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.

6. 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.

7. How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials 10/25/2024

   Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.

8. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

   Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

9. 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.

10. 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.