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.
At the Lectern
MARCH 19, 2025
To equal last term’s output, the court will need to schedule another 29 arguments over this term’s last three calendars. However, the justices’ pace seems likely to still leave the court short of last term’s 58 arguments and opinions (also here ), which was itself one of the court’s lowest numbers historically.
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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. Additional orders from the Sept. 2, at 9:30 a.m.
SCOTUSBlog
OCTOBER 31, 2024
The court on Thursday released the calendar for the January argument session , which will feature nine arguments over five days. During their January argument session, which begins on Jan. 13 and continues until Jan. In Free Speech Coalition v. Free Speech Coalition v. Paxton (Jan. Reynolds Vapor Co.
At the Lectern
JUNE 18, 2024
In Himes , the court in June 2022 agreed to answer these questions posed by the Ninth Circuit: “Under California law, in a claim against a manufacturer of a medical product for a failure to warn of a risk, is the plaintiff required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product?
FDA Law Blog
SEPTEMBER 6, 2023
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.
FDA Law Blog
JANUARY 5, 2023
It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.
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