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Administrative Procedure Act Regulatory Requirements Manufacturers

Beveridge & Diamond PC

Coalition of US States and Cities Lays Groundwork for Legal Challenge of the Department of Energy’s Appliance Efficiency Rollback

Beveridge & Diamond PC on

A multistate coalition of twelve state Attorneys General—California, Connecticut, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Vermont, and Washington—joined by the District of...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

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

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