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New Guidance Comment Period Manufacturers

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Eversheds Sutherland (US) LLP

Treasury and the IRS release much-anticipated guidance, including with respect to the monetization of energy tax credits

On June 14, 2023, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) released a package of much-awaited guidance (the Guidance) consisting of (i) proposed regulations addressing the tax credit...more

Holland & Knight LLP

Treasury Department Issues Section 48D Guidance on CHIPS Act Semiconductor Tax Incentive

Holland & Knight LLP on

The Chips and Science Act of 2022 (CHIPS Act) added Section 48D to the Internal Revenue Code to incentivize the manufacture of semiconductors and semiconductor manufacturing equipment in the United States. The credit is equal...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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