FDA Law Blog

DECEMBER 3, 2023

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”). We do not address the technical and administrative details of the Discount Program here.

Manufacturing 105

Manufacturing Calendaring Statute Administrative Law 105

Customs & International Trade Law

MAY 13, 2022

Here is a recap of the latest customs and international trade law news: FDA. On May 9, 2022, the FDA issued a Constituent Update stating that Glanbia Performance Nutrition (Manufacturing), Inc. The complaint, as supplemented, further alleges that an industry in the United States exists as required by the applicable Federal Statute.

Laws 97

Laws Manufacturing Administrative Law Government 97

Customs & International Trade Law

OCTOBER 28, 2022

DOC is rescinding the administrative review of the countervailing duty (CVD) order on certain non-refillable steel cylinders (non-refillable cylinders) from the People’s Republic China (China), covering the period August 28, 2020, though December 31, 2021. . Secretary of Commerce has determined that U.S. Limited (‘‘Top Golf’’) in default.

Manufacturing 52

Manufacturing Government Laws Administrative Law 52

ClimateChange-ClimateLaw

DECEMBER 11, 2023

Ultimately, the SEC will have to anticipate these types of legal challenges in finalizing a durable rule. When the SEC initially proposed the rule, the Supreme Court had not yet embraced the Major Questions Doctrine (MQD), a new doctrine that constrains the function of the administrative state. Other legal challenges have also arisen.

Legal 62

Legal Legal Court Statute 62

ClimateChange-ClimateLaw

MARCH 13, 2023

In 2021 the Biden Administration reversed the Trump-era rollbacks and instituted the strictest-ever vehicle GHG emissions standards in a move aimed at preventing 3.1 In 2022, Texas, along with several other states and industry groups representing fuel manufacturers (together, Petitioners), challenged EPA’s new emissions standards in court.

Manufacturing 55

Manufacturing Government Court Administrative Law 55

ClimateChange-ClimateLaw

OCTOBER 19, 2023

The Scramble to Identify Major Questions in Administrative Law In its June 2022 decision in West Virginia v. Following the West Virginia decision, analysis of the MQD has proliferated as legal scholars grapple with the doctrine’s lack of definition. However, it objected to the EPA’s interpretation of its authorizing statute.

Statute 81

Statute Court Government Administrative Law 81