FDA Law Blog

APRIL 14, 2022

FDA published in the Federal Register a draft version of its MDUFA V commitment letter , which outlines FDA’s updated performance goals in reviewing device applications and planned process improvements. MDUFA V would be applicable to fiscal years 2023 through 2027.

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Drafting Calendaring Technology 40

FDA Law Blog

DECEMBER 3, 2023

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we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

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Manufacturing Calendaring Statute Drafting 105

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 Notable Dates and Timelines – Inspection tools draft guidance, by Sept.

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Drafting Manufacturing Meetings Minutes Technology 52

LawSites

DECEMBER 4, 2023

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.

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Document Review Court Reporting Metadata Court Reporter 135