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CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction...


The False Claims Act Guide: 2022 and the road ahead

In the latest edition of our False Claims Act Guide: 2022 and the road ahead, we analyze the key developments from 2022 and discuss how the most important cases and issues are shaping FCA...

Insights and Analysis

U.S. FDA regulatory insights: the seemingly shifting landscape of clinical decision support
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Clinical decision support (CDS) software has lately been a focus of discussion between FDA, industry, and other interested parties. CDS tools assist clinicians by analyzing patient data and ...


Major regulatory changes in pharmaceutical laws and regulations in Spain for 2023

The Annual Regulatory Plan for 2023 recently released by the Spanish Government provides for important regulatory changes and developments in the area of medicinal products, including...

Insights and Analysis

Life Science Law Update – Key developments for pharma and device companies in EU and EU Big Five

In this first issue of our quarterly Life Science Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy throughout the...

Insights and Analysis

MDR and IVDR: analysis of the Italian implementing Decrees

On 28 September 2022, Italian Legislative Decrees no. 137/2022 and 138/2022 entered into force. The two Legislative Decrees aim to adjust the Italian legal framework on medical devices to...


O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should...


HHS OIG issues ASP reports exploring need for guidance and increased oversight in ASP reporting

On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP).Fi...


Modernization of U.S. cosmetics regulation will be phased in over time

On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022...

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