Regulatory Insights
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FDA Shifts Reshape Drug Development
6/13/2025
Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.
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We Need Regulatory Clarity—Not Complexity In Clinical Trial Technology
6/12/2025
The current U.S. deregulatory momentum should not diminish compliance standards but instead serve as a call to streamline and modernize regulatory guidance.
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HTA In Japan: The Glass Remains Half Full (For Now)
6/12/2025
While Japan's current HTA system is seen as pro-innovation, potential reforms in 2026 could expand its scope, creating uncertainty for manufacturers in one of the world's largest markets.
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Early Access Program In France: How Much Of An Opportunity Is It?
6/12/2025
Navigating France’s Early Access Program is more complex than ever. Amid declining approval rates and mandatory data collection, here’s what pharmaceutical companies need to know about the changing landscape.
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Inclusion Of Health-Related Quality Of Life (HRQoL) And Other Patient-Reported Outcomes (PROs) In FDA Labels
6/12/2025
With a growing emphasis on patient-centric drug development, new research examines how frequently patient-reported outcomes are actually making it onto United States Food and Drug Administration labels.
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Navigating Special Regulatory Pathways For Advanced Therapy Development Success
6/12/2025
Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.
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Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook
6/12/2025
This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.
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A Roadmap To Expedited Review Pathways
6/12/2025
Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment.
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Explore The 2024 Edition of Industry Pages™ — A Strategic Guide To Running Smarter, Faster, And Leaner Studies
6/10/2025
This 2024 Industry Pages report provides an in-depth examination of the Central and Eastern European (CEE) clinical trial strategy, highlighting its pivotal role in global drug development.
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The Benefits Of U.S. Biotechs Conducting Clinical Trials In Australia
6/5/2025
As U.S. biotech investment continues to rise, cross-border collaboration and trial design innovations are expected to further solidify Australia’s role in the early-stage biotech development pipeline.