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King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

King & Spalding on

On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

Lowenstein Sandler LLP on

The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

Hogan Lovells

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can...

Hogan Lovells on

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more

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