Abstract
There is no such thing as a drug that is 100% safe or effective. Determining whether or not a new oncology treatment (or an additional indication for an existing medicine) should be approved by a regulatory licensing authority is, ultimately, as much regulatory science as public health art and nuance. There are many dynamic shifts in regulatory science (expedited review pathways, biomarker validation, use of real-world evidence, expanded off-label usage, etc) interpreted and expressed within the context of 21st-century oncology drug development, and these new tools and the learnings gleaned from them are helping to advance patient care. They are also helping us to carefully reconsider the levels of uncertainty we find in benefit-risk data and clinical calculations. New-Age Pharmacovigilance can be a tool in product development, regulatory review, postmarketing surveillance and enhanced clinical outcomes.
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References
Conti RM, Berndt ER. Specialty drug prices and utilization after loss of U.S. patent exclusivity, 2001–2007. In: Advances in CRIW Conference Proceedings. Chicago, IL: University of Chicago Press, 2015.
Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study [Review]. BMC Pharmacol Toxicol. 2013;14:1.
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Pitts, P.J., Le Louet, H. & Katz, G. 21st-Century Oncology Drug Safety via New-Age Regulatory Standards and Practices. Ther Innov Regul Sci 53, 701–705 (2019). https://doi.org/10.1177/2168479018809689
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DOI: https://doi.org/10.1177/2168479018809689