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Final Guidance Regulatory Requirements Draft Guidance

Ropes & Gray LLP

FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway”

Ropes & Gray LLP on

In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more

DLA Piper

Food and Beverage News and Trends - January 2025

DLA Piper on

FDA issues final guidance on lead in baby food. FDA has issued its Final Guidance on Action Levels for Lead in Processed Food Intended for Babies and Young Children as part of its Closer to Zero initiative to reduce dietary...more

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