Major U.S. Reform Bill Triggers Regulatory Consequences…
July 4, 2025 – In a move set to reshape key sectors, U.S. President Donald Trump has signed into law H.R.1 – the “One Big Beautiful Bi…
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Regulatory Overview: Bans and Restrictions on Herbal Su…
This article is based on insights generated by RegGenius, RegASK’s AI-driven regulatory intelligence tool. Frequently Asked Questions (FAQ…
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Compliance Has Changed Forever: How Agentic AI Is Rewir…
Our CPTO Amenallah Reghimi explores how agentic AI is transforming compliance from a reactive task into a strategic lever, turning regulator…
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EMA Releases June 2025 PRAC Safety Updates for EU-Autho…
The European Medicines Agency (EMA) has released updated safety signal recommendations from its PRAC committee on June 2, 2025.This update r…
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FDA Launches “Elsa”: Agency-Wide Generative…
On June 2, 2025, the U.S. Food and Drug Administration (FDA) officially launched Elsa, a generative artificial intelligence (AI) tool develo…
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Powering Global Hybrid Clinical Trials: Simplified, Com…
The Challenge A leading global pharmaceutical company was preparing to scale hybrid clinical trials for its Food for Special Medical Purpose…
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Breaking Into the US: Compliant Claims for an Innovativ…
The Challenge Bringing an infant formula to the U.S. market isn’t just about innovation. It’s about navigating one of the most rigorous …
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MAHA Commission Releases Report on U.S. Childhood Chron…
Presidential Commission Releases Landmark Report on U.S. Childhood Chronic Disease Crisis May 22, 2025 – The Presidential Commission to Ma…
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EPA Proposes Renewal of Hazardous Remediation Waste Ove…
May 23, 2025 – The U.S. Environmental Protection Agency (EPA) has proposed a renewal of its Information Collection Request (ICR) related t…
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ANVISA Publishes Preliminary Manual for Brazil’s UDI …
ANVISA Publishes Preliminary Manual for Brazil’s Unique Device Identification (UDI) Database May 28, 2025 – The Brazilian National Healt…
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