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AHRQ Research Studies
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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
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1 to 1 of 1 Research Studies DisplayedHwang TJ, Avorn J, Carpenter D
Quantifying the Food And Drug Administration's rulemaking delays highlights the need for transparency.
In order to better understand the FDA’s rulemaking process, the authors examined the evolution of significant rules that the agency published during 2000–12 for drugs, devices, and other medical products. They found that the rules’ median time to finalization was 7.3 years. Longer review times were significantly associated with a reduction in the stringency of final rules, compared to the originally proposed versions.
AHRQ-funded; HS018465.
Citation: Hwang TJ, Avorn J, Carpenter D .
Quantifying the Food And Drug Administration's rulemaking delays highlights the need for transparency.
Health Aff 2014 Feb;33(2):309-15. doi: 10.1377/hlthaff.2013.0564..
Keywords: Patient Safety, Policy, Decision Making, Medication