Insightful Thought Leadership
Key Takeaways The FDA’s Advanced Manufacturing Technology (AMT) Designation Program, established under Section 506L of the FD&C Act, provides a framework for requesting designation of…
As a student of innovation, I found a new analysis by Georgi Tancev, published in IEEE Transactions on Engineering Management (2026), compelling. Drawing on Paul…
Background Thirteen years after the 2013 edition of PDA Technical Report No. 60 gave the industry its first comprehensive roadmap for implementing the lifecycle approach…
As a CMC and quality expert with over two decades in the biopharma industry, I've had countless conversations with leaders at small biotech companies and…
Executive Summary: The Bottom Line On January 11, 2026, the FDA moved from negotiated flexibility to a standardized flexibility framework for Cell and Gene Therapies (CGT). For our clients, this…
New FDA Draft Guidance on ICH Q3E: What Steps are Needed to Master the Risk-Based Framework for Extractables and Leachables Control? ICH Q3E represents a…
What Are the Best Practices for Bio/Pharma CMC Regulatory Compliance? A Proactive Guide to Documentation and Digital Strategy In the highly scrutinized bio/pharma industry, regulatory…
In January, the Food and Drug Administration (FDA) issued draft guidance on the use of artificial intelligence (AI) models that support regulatory submissions for drug…
Quality by Design (QbD) principles have been incorporated into regulatory guidelines for over two decades, so regulated life science companies are familiar with the requirements…
Last year’s guidance from the FDA regarding human gene therapy products (Human Gene Therapy Products: Incorporating Human Genome Editing Guidance for Industry, FDA January 2024)…