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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 Notable Dates and Timelines – Inspection tools draft guidance, by Sept.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

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This Week in Regulation for Broadcasters: February 20 to February 25, 2023

Broadcast Law Blog

The FCC released a draft Further Notice of Proposed Rulemaking (“FNPRM”) that, if adopted as scheduled at the FCC’s March 16 open meeting, would formally propose to extend the FCC’s existing audio description requirements for broadcast television to DMAs below the top 100 (i.e., See our recent Broadcast Law Blog article for more information.

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Voting Is Open! Pick the 15 Finalists to Compete At Startup Alley at ABA TECHSHOW 2024 in February

LawSites

We are the first AI-driven platform to focus specifically on drafting litigation documents. The substantial amount of time lawyers spend drafting documents during litigation. It also improves access to justice for society as lawyers can handle more cases, as well as remove some bias from the legal system through fact-first drafting.