Titlebook: Cancer Drug Safety and Public Health Policy; A Changing Landscape Charles Bennett,Courtney Lubaczewski,Bartlett With Book 2022 The Editor(s

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Consequences to Patients, Clinicians, and Manufacturers When Very Serious Adverse Drug Reactions ArAdverse drug/device reactions (ADRs) serious enough to lead to box warnings on drug labels or drug withdrawals occur in about one fifth of all new molecular entities.

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Moderna, Pfizer-BioNTech, and Johnson & Johnson/Janssen Post-Covid Vaccine Hematological Adverse EvThe Centers for Disease Control (CDC) indicated in 2021 that it would monitor for possible post-COVID-19 vaccination coagulopathy adverse events (AEs).

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https://doi.org/10.1007/978-3-540-87866-7of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR). Semin Thromb Hemost. 2012;38(08):905–907. .). Prevailing opinion

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Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions,usly approved) biological agents (Kozlowski et al. in N Engl J Med 365:385–388, 2011). The biological epoetin accounts for $1.8 billion in drug spending annually worldwide (primarily for the treatment of anemia due to chronic kidney disease or anemia due to cancer chemotherapy.)

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