Regulatory Affairs Editorial
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Why CRA Proficiency Needs A Boost From Better Assessment And Training
6/20/2025
CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.
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EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?
6/19/2025
The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025
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25 Tips To Prepare A Clinical Site For FDA Inspection
6/17/2025
During the last year I have interviewed six former FDA investigators and a regulatory expert who has been involved with more than 250 inspections. From all those interviews, I’ve culled the following list of takeaways that I hope you will find useful when preparing for any type of regulatory inspection.
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2 Ways To Overcome The Challenge Of Developing Neurological Rare Diseases Drugs
6/16/2025
GRIN Therapeutics CEO Bruce Leuchter, MD, explores how integrating new business models and technological advances will be crucial to developing new treatments for rare neurological disorders.
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Hidden Compliance Risks In Start-Up That Could Derail Your Clinical Trial
6/13/2025
Kulkarni Law Firm Senior Attorney Edye T. Edens explores the risks embedded in clinical trial start-up activities, such as site activation, contract execution, delegation of responsibilities, and cross-border data flows.
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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.