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Warning Letters Artificial Intelligence

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more

Troutman Pepper Locke

Bipartisan Group of AGs Issue Warning Letter Over Alleged Election Robocalling

Troutman Pepper Locke on

On February 6, a bipartisan group of 51 attorney general (AG) sent a warning letter to Life Corporation (Life Corp.) for allegedly engaging in an illegal robocall campaign that they claim was intended to deter New Hampshire...more

Wiley Rein LLP

Wiley Consumer Protection Download (December 4, 2023)

Wiley Rein LLP on

Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

Lighthouse

2021 Second Request Trends Report - A Look At HSR Second Requests In 2021 And What We Can Expect For 2022

Lighthouse on

Federal agencies don’t publish official Second Request transaction numbers until late the following year. But recent trends suggest a high volume of activity for 2021 and 2022, as well as a stricter regulatory and political...more

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