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A Court-Side Seat: SCOTUS Rulings, the Fiscal Responsibility Act and the October 2023 Calendar

Gravel2Gavel

Rulings in several cases will affect the practice of regulatory and administrative law either directly or indirectly, as is recounted below. Before the Court adjourned, it released its calendar of cases to be argued in October 2023, and of course, more cases will be scheduled after the Court returns. Continue Reading ›

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. We do not address the technical and administrative details of the Discount Program here. The manufacturer will have 60 days to appeal the CMP before an administrative law judge (ALJ).

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Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?

FDA Law Blog

Rather, the bill is structured so that liability is fully determined by an Administrative Law Judge (“ALJ”) in an administrative proceeding without a jury, with “conclusive” factual findings made by that ALJ.

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

Broadcast Law Blog

In these markets, “Big Four” stations (ABC, NBC, CBS, and Fox) are required to provide 50 hours of audio description per calendar quarter, either during prime time or in children’s programming, and 37.5 additional hours of audio description per calendar quarter between 6 a.m. and 11:59 p.m. local time.