Clinical Supply Regulatory Articles

31. 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.

32. 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.

33. FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay 10/4/2023

    On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.

34. 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.

35. 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

36. What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production 3/8/2024

    Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.

37. 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.

38. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

    How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

39. 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.

40. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.