Regulatory Affairs Editorial

31. Running Global Clinical Trials? PolyPid Shares Operational And Regulatory Insights 8/11/2025

    PolyPid shares its clinical trial journey across the U.S., Europe, and Israel, highlighting operational complexities, regulatory navigation, and the adaptability required to execute large-scale, global studies. 

32. Heart-In-A-Jar Organ Model Earns Regulatory Respect After 25 Years In The Making 8/7/2025

    Aligned with new FDA support for new approach methodologies (NAMs), Ronald Li, Ph.D, and Kevin Costa, Ph.D., share their story of creating Novoheart's mini heart organ model and discuss its current use in clinical trials.

33. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

34. What's Clinical Liability Insurance, And How Does It Work? 8/5/2025

    Life science insurance specialist Kristin Beaulieu explains why sponsors must develop a strategy for scaling their product liability insurance program, detailing two main product liability types to consider.

35. 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution 7/29/2025

    Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.

36. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.

37. All Of Us Need To Be Rooting For The FDA 7/23/2025

    In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.

38. What Sponsors Must Know About Digital Systems And AI Compliance 7/17/2025

    Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.

39. How To Avoid Hazards And Map A Safer, Smarter Path For AI, Part 2 7/15/2025

    The AI journey is full of hidden potholes, unexpected detours, and costly wrong turns. In part two of this series, Tanisha Patel and Vincent Puglia explore more considerations for integrating AI in clinical research.

40. How To Avoid Hazards And Map A Safer, Smarter Path For AI, Part 1 7/15/2025

    Even with a clear destination with real rewards, the AI journey is full of hidden potholes, unexpected detours, and costly wrong turns. Tanisha Patel and Vincent Puglia explore several considerations when integrating AI in clinical research.