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…
Leer más
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…
Leer más
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…
Leer más
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 …
Leer más
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 …
Leer más
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…
Leer más
EPA Proposes Renewal of Hazardous Remediation Waste Ove…
EPA Proposes Renewal of Hazardous Remediation Waste Oversight May 23, 2025 – The U.S. Environmental Protection Agency (EPA) has proposed a…
Leer más
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…
Leer más
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…
Leer más
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…
Leer más