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Over the 3 calendar quarters (4Q2023, 1Q2024, and 2Q2024), our proposed approach for calculating the payment limit for biosimilars with only negative or zero ASP and the two alternative approaches would have reduced program expenditures by at least $821,599.473, $914,463.917, and $1,148,055.145, respectively

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(3) For a Part B rebatable drug first approved or licensed by the FDA on or before December 1, 2020, but with a first marketed date after December 1, 2020, the payment amount benchmark quarter is the third full calendar quarter after a drug's first marketed date

With e-cigarette use now epidemic among teens, and cigarettes still the leading cause of preventable death in the United States, the Food and Drug Administration announced on Thursday a series of moves meant to drive young people away from tobacco products