Regulatory Insights
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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.
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Ensuring Compliance When Using Wearables In Clinical Trials
6/4/2025
As wearable technology takes on a central role in clinical research, explore how its benefits can be maximized while navigating the increasing complexity of regulatory compliance.
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Decentralized Trials And Community-Based Research Execution And Compliance
5/28/2025
The FDA's regulatory endorsement of DCTs enhances their credibility, offering a pathway to more inclusive and accessible clinical research that benefits both patients and sponsors.
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RWD's Significance In The Largest FDA-Funded IOL Study Of Pediatric Patients
5/28/2025
With FDA grant support, the American Academy of Ophthalmology and Verana Health conducted the largest real-world study to date on intraocular lens (IOL) use in pediatric cataract patients.
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The Makings Of 'Regulatory-Grade' RWD In Ophthalmology Using AI
5/25/2025
Regulatory bodies like the FDA and EMA now prioritize real-world data in clinical research. Learn more about its value in enhancing drug development, regulatory decisions, and patient outcomes.