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Administrative Procedure Act New Guidance Proposed Rules

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Issues Additional Information on New Pre-Institution Discretionary Briefing

On April 25, 2025, the USPTO issued additional information in response to frequently asked questions (FAQs) about the “Interim Processes for PTAB Workload Management” memorandum issued on March 26, 2025. As discussed in our...more

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