Tag: drug safety

Accessing FDA Adverse Event Databases: How to Use Public Tools for Safety Monitoring

Posted by Paul Fletcher
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Accessing FDA Adverse Event Databases: How to Use Public Tools for Safety Monitoring

Learn how to access and use the FDA's public adverse event database (FAERS) to monitor drug safety. Explore tools, understand limitations, and avoid common mistakes in interpreting real-world side effect data.

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Causality Assessment for Adverse Drug Reactions: How the Naranjo Scale Works in Real-World Practice

Posted by Paul Fletcher
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Causality Assessment for Adverse Drug Reactions: How the Naranjo Scale Works in Real-World Practice

The Naranjo Scale is a proven, 10-question tool used worldwide to determine if a drug caused an adverse reaction. Learn how it works, where it falls short, and why it's still the gold standard in drug safety.

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Real-World Evidence Sources for Drug Safety: Registries and Claims Data Explained

Posted by Paul Fletcher
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Real-World Evidence Sources for Drug Safety: Registries and Claims Data Explained

Real-world evidence from patient registries and claims data is now essential for monitoring drug safety after approval. Learn how these sources help regulators catch rare side effects and ensure medications are safe for millions.

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