Clinical Supply Regulatory Articles

31. 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.

32. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

    A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

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. Vendor/Supplier Management To Maintain A Drug's Safety Profile In End-To-End Supply Chain Planning 8/17/2023

    FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.

35. 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.