Drug Shortages Threaten Patient Safety in Africa
The U.S. Agency for International Development (USAID) is responsible for nearly 70% of American global health aid [9]. As a result, recent p…
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The Future of RegTech in Medical Devices & SaMD: 8…
Emerging technologies like artificial intelligence, predictive analytics, and blockchain are redefining how medical devices and Software as …
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European Commission Launches Public Consultation on Upd…
On July 7, 2025, the European Commission’s Directorate-General for Health and Food Safety opened a public consultation on proposed revisio…
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Enhancing Food Risk Intelligence for a Global Nutrition…
The Objective A global nutrition leader needed to enhance the visibility and responsiveness of food regulatory changes across global markets…
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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. The Essentials Table of Content…
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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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