Lauren Roth

Lauren Roth

King & Spalding

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FDA Issues Two Guidances For the Device Q-Sub Process

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

6/5/2025  /  Compliance , Draft Guidance , Food and Drug Administration (FDA) , Government Agencies , Medical Devices , New Guidance , Regulatory Agenda , Regulatory Oversight , Regulatory Requirements , Rulemaking Process

FDA Releases Proposed Front-of-Package Nutrition Labeling Rule

On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) nutrition labeling (“proposed rule”)....more

1/28/2025  /  Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Labeling , Government Agencies , Labeling , Nutrition Facts Labels , Proposed Rules , Public Health , Regulatory Agenda , Rulemaking Process
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