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. 2021 Mar;68(3):e28871.
doi: 10.1002/pbc.28871. Epub 2020 Dec 31.

The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority-An oncology perspective

M Brooke Bernhardt  1   2 , Holly Lindsay  1   2 , Wendy Allen-Rhoades  1   2 , Jennifer H Foster  1   2
Affiliations

The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority-An oncology perspective

M Brooke Bernhardt et al. Pediatr Blood Cancer. 2021 Mar.

Abstract

The scarcity of adequate pediatric drug labeling information has long been problematic in the pediatric population, which may place children at risk for adverse drug effects. The ontogeny of infants, children, and adolescents over the course of the first two decades of life pose complex pharmacokinetic, dosing, administration, effectiveness, and toxicity-related questions that require specific investigation. Here, we review the history that led to the passage of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), and provide commentary on issues relevant to pediatric oncology now and in the future.

Keywords: Best Pharmaceuticals for Children Act; PediatricResearch Equity Act; drug labeling; research.

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References

REFERENCES

    1. Deaths due to elixir of sulfanilamide-Massengill: report of the Secretary of Agriculture submitted to House Resolution 352 of November 19, 1937 and Senate Resolution of November 16, 1937. JAMA. 1937;109:1985-1988
    1. Taussig HB. A study of the German outbreak of phocomelia. JAMA. 1962;198:1106-1114.
    1. Lenz W. A study of the German outbreak of phocomelia. Lancet. 1962;2:1332.
    1. Burns LE, Hodgman JE, Cass AB. Fatal circulatory collapse in premature infants receiving chloramphenicol. N Engl J Med. 1959;261:1318-1321.
    1. Sutherland JM. Fatal cardiovascular collapse of infants receiving large amounts of chloramphenicol. AMA J Dis Child. 1959;97:761.

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