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  1. Office of Economics and Analysis

OEA Research & Analysis

OEA conducts economic, public health, social science, and operations research as a basis for forecasting trends, needs, and major problems requiring solutions, and provides assistance and consultation in these areas to FDA leadership and operating units.

For Economic Impact Analyses of FDA Regulations, please click here.

Economics Staff Research & Publications
PHSA Research & Publications

 

What's New:

  • The latest on expedited drug development
    New OEA research, published in JAMA Network Open, suggests that FDA's expedited drug development and review programs have an increasing role in bringing novel drugs to market in the US, especially orphan and biologic products.

    Among the 581 FDA-approved pairs of novel drugs and indications, use of expedited development and review programs increased from 42.3% of pairs in 2008 to 74.5% in 2021.

  • Characteristics of medical device shortages in the U.S.
    Although medical device shortages were a significant concern during the COVID-19 pandemic, a new OEA study in Health Affairs found that shortages are neither a new phenomenon nor the result of the pandemic alone.

    From 2010 to 2019, the U.S. experienced on average about five medical device shortages annually - a number that increased fourfold in the first half of 2020.

    The study also found that most 2020 shortages were triggered by the pandemic, while pre-2020 shortages stemmed from regulatory and enforcement actions related to product quality and manufacturing, discontinuances, natural disasters, and other triggering events.

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