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Notice of Proposed Rulemaking (NOPR) › Food and Drug Administration (FDA) › Rulemaking Process

Venable LLP

FDA Announces Notice of Proposed Rulemaking to Eliminate Self-Affirmed GRAS and Revise GRAS Review Criteria

Venable LLP on

Last week, the Office of Information and Regulatory Affairs released the spring 2025 edition of the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). This semiannual publication outlines the...more

Mintz - Health Care Viewpoints

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

Mintz - Health Care Viewpoints on

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally accepted standard for...more

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