Clinical Supply Regulatory Articles

1. 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.

2. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

   The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

3. Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide 10/4/2024

   ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders. 

4. 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.

5. Considerations For Potency Assurance Of CGT Products 11/12/2024

   Confused about FDA's draft guidance on potency assays for cell and gene therapy products? Let's clarify a few things and discuss some key considerations.

6. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

   The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

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   FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.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

9. 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.

10. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

    How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.