In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This ...
Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for ...
In this podcast, Jason Reddish, Principal and Mark Ogunsusi, Associate, at Powers Pyles Sutter & Verville provide an overview of the program and the compliance requirements. They are also two of the ...
Medical device makers must comply with the US Food and Drug Administration’s (FDA) Quality Management System Regulation (QMSR) after the rule took effect on Monday. Additionally, FDA inspections of ...
Risk management is a major emphasis of FDA’s new compliance program, the Quality Management System Regulation (QMSR), and companies should expect to see big differences in how the agency will conduct ...
FDA is seeking additional authorities and funding in its fiscal 2025 budget request to enhance its oversight – and by extension safety enforcement – of new food ingredients, additives and contact ...
The Food and Drug Administration (FDA) lacks certain authorities and is persistently underresourced to fulfill its mission of protecting the public by ensuring that foods are safe, wholesome, sanitary ...
FDA’s fiscal year 2025 priority deliverables for the Human Foods Program emphasize transparency and accountability amid state funding cuts and resource constraints. With the establishment of the new ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...
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