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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Esko and RegASK Partner to Transform Packaging Complian…
ST. LOUIS & NEW YORK–(BUSINESS WIRE)–RegASK, a leading provider of AI-driven regulatory intelligence for Consumer Goods and …
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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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California Suspends Proposed Bill Restricting Sale of A…
On May 15, 2025, the California Legislature paused Assembly Bill 728 (AB 728), a proposed law that would restrict the sale of certain over-t…
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FSANZ Notifies Draft Code Changes to Infant Formula Sta…
FSANZ Proposes New Standards for Infant Formula Products in Australia Food Standards Australia New Zealand (FSANZ) has released draft change…
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HHS and FDA Request for Information: Identifying Unnece…
On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for…
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