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Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration

David Croteau, Ellen Pinnow, Eileen Wu, Mónica Muñoz, Ilynn Bulatao, Gerald J. Dal Pan

Drug Safety · 2022 · 27 citations · 3 references

DOI

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References

3

Evaluation of FDA safety‐related drug label changes in 2010

Jean Lester, George A. Neyarapally, Earlene E. Lipowski et al. · Pharmacoepidemiology and Drug Safety · 2013 · 112 citations

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Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014

Ellen Pinnow, Sania Amr, Søren M. Bentzen et al. · Clinical Pharmacology & Therapeutics · 2017 · 59 citations

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Examination of the Relationship Between Oncology Drug Labeling Revision Frequency and FDA Product Categorization

Robert J. Berlin · American Journal of Public Health · 2009 · 15 citations · Full text

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