Clinical Supply Regulatory Articles

31. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

    The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

32. 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.

33. 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.

34. 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?

35. 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. 

36. 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.

37. 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.

38. 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.

39. 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.

40. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

    The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.