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.
Customs & International Trade Law
APRIL 22, 2022
As of April 19, 2022, the FDA has issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing hydroquinone that do not meet the requirements to be legally sold as OTC drugs. FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products.
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Fordham Law News
NOVEMBER 18, 2022
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.
FDA Law Blog
JANUARY 15, 2024
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.
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. Glanbia), along with 10 other companies, was illegally selling adulterated dietary supplements. On May 1, 2022, the U.S.
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.
Customs & International Trade Law
NOVEMBER 4, 2022
Department of the Treasury’s Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied. . 731–TA–860 (Final). .
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