Clinical Supply Regulatory Articles

1. 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.

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 Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

   FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical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

3. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

   ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

4. 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.

5. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

   This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

6. 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.

7. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

   The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

8. 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   Confused about FDA's draft guidance on potency assays for cell and gene therapy products?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.

9. New Initiative Seeks To Back Up ICH's Harmonization Mission 5/3/2024

   An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.

10. What Global Survey Says About Scant Patient Access To CAR-T Therapy 6/17/2025

    The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.