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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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A Court-Side Seat: OSHA, Air and Waters

Gravel2Gavel

The courts have issued several new and significant rulings on environmental and administrative law the past few weeks. Truck Trailer Manufacturers Association, Inc. by Anthony B. COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT.

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Reframing ITC’s Role: The Advancing America’s Interests Act

Patently O

Anti-dumping and Countervailing Duties : The ITC can impose anti-dumping duties on foreign manufacturers selling goods in the U.S. The ITC has the power to issue an exclusion order — much like an injunction — to bar infringing products from entering the US. at less than fair value. — i.e., non practicing entities.

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A Court-Side Seat: SCOTUS Decides Another Regulatory “Takings” Case; A Flurry of Action at EPA

Gravel2Gavel

This is a brief account of some of the important environmental and administrative law cases recently decided. by Anthony B. SUPREME COURT . City and County of San Francisco. On June 28, 2021, the Supreme Court decided the case of Pakdel v. City and County of San Francisco. Comments are due by August 27, 2021.

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Immigration, takings, administrative law and the kitchen sink

SCOTUSBlog

The city condemned it so it could be used as part of the campus for an existing chocolate factory, as part of a larger plan to create a “planned manufacturing district.” The court also has a pair of new administrative law cases, both captioned American Hospital Association v. Becerra and with consecutive numbers.

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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

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Illumina’s Acquisition of GRAIL: A Comparison of the Outcomes

Fordham Law News

5] A vertical merger is defined as “a merger between businesses occupying different levels of operation for the same product, such as between a manufacturer and a retailer.” [6] In September 2022, Administrative Law Judge Chappell dismissed the FTC’s charges against Illumina. [11] 6] Merger , Black’s Law Dictionary (11th ed.