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Mar 25th, 2026

FDA Warning Letter to a Global Specialty Pharma Company: Critical Pharmacovigilance Compliance Lessons

Pharmacovigilance teams face increasing pressure to detect and report safety signals quickly and accurately. While quantitative methods like disproportionality analysis help flag potential signals, regulatory expectations now demand a thorough…

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Mar 17th, 2026

FDA Launches Unified Adverse Event Monitoring System (AEMS) to Modernize Safety Surveillance

Pharmacovigilance teams face increasing pressure to detect and report safety signals quickly and accurately. While quantitative methods like disproportionality analysis…

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Aug 19th, 2025

Advancing Signal Detection and Reporting: Integrating AI in Pharmacovigilance

Pharmacovigilance teams face increasing pressure to detect and report safety signals quickly and accurately. While quantitative methods like disproportionality analysis…

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Jul 7th, 2025

Beauty Under Scrutiny: How Cosmetics Brands Are Battling Fraud and Fortifying Safety

In a world where appearance is currency and skincare routines are sacred, the cosmetic industry stands as a multi-billion-dollar titan.…

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Jun 5th, 2025

Advancing Signal Management: Aligning with Good Pharmacovigilance Practice Module IX Using AI-Powered Pharmacovigilance

In today’s high-stakes pharmaceutical environment, patient safety is no longer merely a regulatory checkbox—it is the cornerstone of public trust,…

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Mar 17th, 2025

MoCRA and Global Regulations: Aligning US Compliance with International Standards

The Modernization of Cosmetics Regulation Act (MoCRA) 2022 has introduced significant changes to US cosmetics regulations. This new law modernizes…

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Mar 16th, 2025

Cosmetic Safety in the Age of MoCRA: Leveraging AI to Stay Ahead of Compliance and Generate Maximum Business Value

As the cosmetics industry faces increasing regulatory scrutiny under the Modernization of Cosmetics Regulation Act (MoCRA), brands must adapt quickly…

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Nov 20th, 2024

AI Adoption: A Simple Framework for Risk Management

With Artificial Intelligence (AI) in general, and Generative AI in particular becoming the next big thing in technology, we see…

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Oct 28th, 2024

Presentation: AI in Drug Safety Operations – The Future is Here!

Narasimha Kumar, Chief Product Officer at Datafoundry, delivered an engaging presentation titled “AI in Drug […]

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Jul 18th, 2024

10 Ways AI-Powered Literature Monitoring Boosts Productivity

In the world of safety vigilance, the meticulous task of literature surveillance is crucial for ensuring patient safety and health…

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