Grace Gluck

Arnall Golden Gregory LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

6/5/2025 / Algorithms , Artificial Intelligence , Biotechnology , Clinical Trials , Food and Drug Administration (FDA) , Healthcare , Machine Learning , Medical Devices , Regulatory Oversight , Regulatory Requirements

Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more

5/1/2025 / Advertising , Clinical Trials , Disclosure Requirements , Enforcement Actions , False Advertising , Food and Drug Administration (FDA) , Marketing , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

3/26/2025 / Compliance , Draft Guidance , Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Public Health , Regulatory Requirements , Risk Management , Warning Letters

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