McKenzie Cato

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

6/5/2025 / Compliance , Draft Guidance , Food and Drug Administration (FDA) , Government Agencies , Medical Devices , New Guidance , Regulatory Agenda , Regulatory Oversight , Regulatory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 Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review

On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more

5/20/2025 / Algorithms , Artificial Intelligence , Biologics , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda , Regulatory Requirements

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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