#JoeRoss

2025-06-06
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2022-11-21

Great to see new attention to this study showing unintended consequences to #FDA's Unapproved Drugs Initiative - also a great example of how #HealthServicesResearch can contribute to policy change, since the UDI was terminated in 2020, citing this work: govinfo.gov/content/pkg/FR-202 #HealthPolicy #RxPolicy

QT @iwashyna
ok, like half of the useful non-antibiotic #ICU #drugs are apparently #UnapprovedByFDA

Source: #RaviGupta #JoeRoss in pubmed.ncbi.nlm.nih.gov/289447

Table 1. Characteristics of Previously Unapproved Drugs Facing UDI Regulatory Action or Receiving Voluntary Approval (N=34)Table 2. Clinical Evidence Supporting NDA Approval of Prescription Drugs After Facing UDI Regulatory Action or Receiving Voluntary Approval (N=19)

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