LAUSR

Bridging Animal and Human Data in Pursuit of Vaccine Licensure

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2 Published in 2022 at "Vaccines"

DOI: 10.3390/vaccines10091384

Abstract: The FDA Animal Rule was devised to facilitate approval of candidate vaccines and therapeutics using animal survival data when human efficacy studies are not practical or ethical. This regulatory pathway is critical for candidates against… read more here.

Keywords: animal rule; vaccine licensure; animal human; licensure ... See more keywords