Cell and Gene Regulatory

31. Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation 4/15/2026

    Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.

32. Expert Q&A: What A Submission-Ready E&L Strategy Really Looks Like 4/14/2026

    Underestimating E&L risks can delay approvals. A risk‑based, product‑specific approach — supported by strong analytics and toxicology — helps teams identify issues early and move forward with confidence.

33. FDA's New Flexible CMC Framework For CGT 4/14/2026

    The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

34. Why Requalify? 4/14/2026

    Qualification is not a one-and-done activity in regulated environments. Learn when requalification is required and how lifecycle-based testing helps ensure equipment performance and compliance.

35. What FDA CRLs Reveal About Method Validation 4/14/2026

    FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

36. What FDA CRLs Reveal About CCIT 4/14/2026

    FDA rejection letters show common CCIT gaps — low sensitivity and incomplete validation. Spotting these trends helps teams strengthen integrity testing and avoid approval delays.

37. Understanding And Implementing USP <665> For Single-Use Systems 4/14/2026

    New expectations for single-use systems require structured risk assessment and extractables testing. As compliance deadlines near, practical guidance aligns science, knowledge, regulatory readiness.

38. How To Implement Post-Approval Changes On A Global Level 4/14/2026

    To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

39. From Bench To Approval: Smart IVBE Strategies For Complex Drugs 4/10/2026

    In vitro bioequivalence can replace clinical studies for complex products when well designed. Clinically relevant, risk-based methods under realistic conditions show site-of-action equivalence.

40. Maintain Control Of Pharmaceutical Water Systems 4/10/2026

    Early TOC excursions often reveal hidden risks in water systems. Capturing samples at the moment of deviation helps teams confirm root causes faster, reduce uncertainty, and maintain control.