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”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.
SCOTUSBlog
APRIL 2, 2025
A 2009 law, the Family Smoking Prevention and Tobacco Control Act, requires manufacturers to get permission from the FDA before putting a new tobacco product on the market. The FDA had told manufacturers that the submission of such plans would be critical but then did not consider them, the companies complained.
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SCOTUSBlog
JUNE 24, 2021
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.
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.
Gravel2Gavel
NOVEMBER 22, 2021
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.
Patently O
JUNE 20, 2023
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.
Customs & International Trade Law
APRIL 22, 2022
Some manufacturers and distributors have already removed their OTC skin lightening products from the marketplace, and FDA plans to take action against those continuing to market these potentially harmful and illegal OTC products. FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products.
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