2025 Calendaring Manufacturing 
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
OCTOBER 31, 2024
The court on Thursday released the calendar for the January argument session , which will feature nine arguments over five days. Share The Supreme Court will hear an important First Amendment case on Jan. During their January argument session, which begins on Jan. 13 and continues until Jan. 13 and continues until Jan. Paxton (Jan.
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Strictly Business
FEBRUARY 29, 2024
For those reporting companies established or registered before January 1, 2024, the deadline for the initial BOI report is January 1, 2025. CTA compliance is something businesses and business owners must take seriously.
Broadcast Law Blog
FEBRUARY 27, 2023
In these markets, “Big Four” stations (ABC, NBC, CBS, and Fox) are required to provide 50 hours of audio description per calendar quarter, either during prime time or in children’s programming, and 37.5 additional hours of audio description per calendar quarter between 6 a.m. and 11:59 p.m. local time.
FDA Law Blog
JULY 7, 2024
Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.
FDA Law Blog
SEPTEMBER 20, 2021
Notable Dates and Timelines – Program opens, beginning of FY 2023; Expediting reviews fully implemented, by FY 2024; Webpage with detailed criteria for acceptance and participation, October 1, 2022; Interim assessment, end of FY 2025; Public workshop, end of Q2 FY 2026. Notable Dates and Timelines – New MAPP published, by Dec.
FDA Law Blog
SEPTEMBER 14, 2021
Beginning in 2025, payment for certain “Selected” single source drugs under Parts B and D, and under commercial plans that do not opt out of the program, would be limited to a Maximum Fair Price (MFP). In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.
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