Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine

IMPORTANCE: Off-label treatment was common for ophthalmia neonatorum because only erythromycin ointment had been approved by the US Food and Drug Administration (FDA) for this indication. Ophthalmia neonatorum was previously considered a different indication from bacterial conjunctivitis in older ch...

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Vydáno v:JAMA Ophthalmol
Hlavní autoři: Sun, Haihao, Temeck, Jean W., McCune, Susan K., Chambers, Wiley A.
Médium: Artigo
Jazyk:Inglês
Vydáno: American Medical Association 2020
Témata:
Brief Report
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC7747033/
https://ncbi.nlm.nih.gov/pubmed/33331874
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamaophthalmol.2020.5558
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