Concepedia

Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

Andrea N. Monge, Daniel W. Sigelman, Robert J. Temple, Harinder Singh Chahal

JAMA Network Open · 2022 · 29 citations · 16 references

DOIFull text

Open access

Abstract

The study showed that use of the FDA's expedited programs to bring novel drugs to market in the US increased from 2008 to 2021. The findings suggest that this trend is likely to continue.

References

16

FDA Approval and Regulation of Pharmaceuticals, 1983-2018

Jonathan J. Darrow, Jerry Avorn, Aaron S. Kesselheim · JAMA · 2020 · 336 citations

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

Nicholas S. Downing, Nilay D. Shah, Jenerius A. Aminawung et al. · JAMA · 2017 · 310 citations · Full text

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

Aaron S. Kesselheim, Bo Wang, Jessica M. Franklin et al. · BMJ · 2015 · 184 citations · Full text

Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study

Sana Mostaghim, Joshua J. Gagne, Aaron S. Kesselheim · BMJ · 2017 · 104 citations · Full text

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines

Thomas J. Hwang, Jessica M. Franklin, Christopher T. Chen et al. · Journal of Clinical Oncology · 2018 · 99 citations

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