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FDA Issues Final Rule On Regulation Of Laboratory Developed Tests - Life Sciences, Biotechnology & Nanotechnology

On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). ....

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Alvotech And Teva's Selarsdi™ (ustekinumab-aekn), Biosimilar To Stelara® Approved By FDA - Life Sciences, Biotechnology & Nanotechnology

According to an April 2024 press release, Alvotech and Teva's Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson's Stelara® (ustekinumab). ....

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The Regulatory Race Is On: The Biden Administration Sprints To Issue Key Health Policies - Healthcare

The upcoming election, and the approaching end of the President's four-year term, introduce additional dynamics into the agencies' rulemaking process and even the guidance process. ....

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False Claims Act Settlements To Know From Q1 2024 - Healthcare

Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements. ....

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Red Alert On The Orange Book: The FTC Continues To Crack Down On Improperly Listed Drug Patents - Patent

As reported in an earlier Client Alert, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration's "Approved Drug Products. ....

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