Clinical Supply Regulatory Articles

1. 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.

2. 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.

3. 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.

4. Strategic Procurement For Emerging Pharmas & Biotechs 2/27/2023

   Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

5. FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission 10/18/2024

   The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.

6. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

   Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

7. 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.

8. 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.

9. 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.

10. FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

    This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.