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Regulatory Requirements Appeals Marketing

Buchalter

9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

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The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

BakerHostetler on

In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more

Troutman Pepper Locke

Supreme Court Says Affected Retailers May Challenge ENDS Manufacturer’s Marketing Denial Orders

Troutman Pepper Locke on

On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more

Troutman Pepper Locke

Supreme Court Weighs Vape Venue Dispute

Troutman Pepper Locke on

On January 21, the Supreme Court heard arguments in a case addressing who may challenge Food and Drug Administration (FDA) marketing denial orders for new tobacco products....more

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