Calendaring Manufacturing Statute 
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
SEPTEMBER 29, 2023
The question comes to the court in the case of George Sheetz , who in 2016 applied for a permit to build a 1,854-square-foot manufactured home on land that he owns in Placerville, California. The post Twelve cases added to Supreme Court calendar appeared first on SCOTUSblog. In Corner Post v. Warner Chappell Music v. 2, at 9:30 a.m.
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FDA Law Blog
SEPTEMBER 30, 2024
CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. that is not supported by the statute and applicable regulations.”
FDA Law Blog
JUNE 2, 2023
Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.
SCOTUSBlog
OCTOBER 12, 2023
4 in the challenge to the legality of the bankruptcy plan for Purdue Pharma, the manufacturer of the highly addictive opioid painkiller OxyContin. The argument in the Purdue Pharma case is one of eight cases scheduled for seven hours of oral argument in the court’s December argument calendar , which was released on Thursday morning.
FDA Law Blog
JUNE 16, 2023
Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?
SCOTUSBlog
NOVEMBER 17, 2023
Raimondo headline the calendar for the January argument session , which the court released on Friday morning. Natural Resources Defense Council , in which the court held that when a federal statute is ambiguous, courts should defer to an agency’s interpretation of that law as long as it is reasonable. Relentless, Inc.
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