Regulatory Affairs Editorial
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A Look At Elsa, The FDA's New AI Digital Assistant
6/12/2025
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.
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Insights From 250+ Regulatory Inspections
6/10/2025
Elisabeth George, who has led more than 250 FDA inspections, shares practical advice for hosting audits — including preparation tips, team coordination, live documentation, and knowing exactly when to speak.
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U.S. Tariffs And Their Tenuous Impact On Clinical Trials
6/10/2025
RSM US LLP Life Sciences Senior Analyst Amanda Laskey discusses Trump administration tariffs and how they're expected to impact the pharma world, specifically clinical research.
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6 Tips To Ensure Revenue Integrity And Compliance In Clinical Operations
6/9/2025
Discover the importance of Medicare Coverage Analysis (MCA) and the rules of National Coverage Determination (NCD) in establishing financial security and regulatory adherence in clinical operations.
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Everything To Know About Long-Term Data Collection For Cell And Gene Therapy Trials In The EU
6/4/2025
Discover how to secure uninterrupted access to long-term trial data for CAR-T therapies by participating in the European Society for Blood and Marrow Transplantation (EBMT) CAR-T Data Collection Initiative.
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Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations
6/2/2025
The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).
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Why Perfect Clinical Trial Data Is A Dangerous Myth
6/2/2025
Former FDA inspector Kara Harrison reveals clinical trials fail due to overcomplex designs, checklist-driven monitoring that misses critical issues, and lack of focus on what actually matters for patient safety and data integrity.
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Here's Your 483 — And Your Hug
5/27/2025
Former FDA inspector Tracey Harris shares what clinical sites get right, what they botch completely, and why inspection readiness is about more than coffee, binders, or bluffing.
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Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services
5/22/2025
The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?
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Spiders, Mold, & SOPs: Tales From A Site Inspection Veteran
5/22/2025
Sarah Moeller, a veteran of mock regulatory inspections, shares lessons from over 300 site visits, emphasizing preparation, documentation, and patient-focused practices to ensure sites are inspection-ready.