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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

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.

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A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

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The Clean Energy Investment Tax Credit (ITC): Direct Pay Claimants’ Race Against Time

ClimateChange-ClimateLaw

In 2025, that reduction in base credit will increase to 15 percent and in 2026, the base credit amount for direct pay claimants that cannot achieve the domestic content requirements will be reduced by 100 percent. In short, that the IRA could have been better drafted does not mean that nontaxpayers shouldn’t take full advantage.

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Customs and Trade News Weekly Snapshot

Customs & International Trade Law

Annual quota opening February 7, 2024: QB 24-507 2024 Solar Cells and Modules – Crystalline Silicon Photovoltaic (CSPV) Solar Cells February 7, 2024, to February 6, 2025 – 5,000,000,000 watts (5.0 million, had the merchandise been genuine.

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Customs and Trade News Weekly Snapshot

Customs & International Trade Law

is working on draft legislation that would “compel” the FMC and STB to draft a memorandum of understanding over which agency has authority over international intermodal freight. 31, 2025, in implementing the import provisions of the Marine Mammal Protection Act (MMPA). John Garamendi, D-Calif.,

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

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 – Inspection tools draft guidance, by Sept.

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March Regulatory Dates for Broadcasters – Comment Dates on FCC Ownership Rules, FTC Proposed Ban on Noncompete Agreements, and TV Captioning Rules; Higher FCC Application Fees; Daylight Savings Time Adjustments for AM Stations; and More

Broadcast Law Blog

At its March 16 regular monthly open meeting, the FCC will consider a draft Further Notice of Proposed Rulemaking (“FNPRM”) that, if adopted, would formally propose to extend the FCC’s existing audio description requirements for broadcast television to DMAs below the top 100 (i.e., DMAs 101-210). and 11:59 p.m. local time.