Abstract
The US Food and Drug Administration’s Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical. In November, 2015 BioThrax became the first vaccine to receive approval for a new indication via this pathway. The basis for this approval and use of Animal Rule or other non-traditional approval pathways for licensure of vaccines for serious conditions are discussed.
Highlights
The US Food and Drug Administration’s Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical
On 23 November 2015, BioThrax (Anthrax Vaccine Adsorbed) became the first vaccine to receive approval for a new indication based on the US Food and Drug Administration’s (FDA) Animal Rule.[1,2]
BioThrax was originally licensed in the 1970s and is the only vaccine approved in the United States for human use in prevention of inhalational anthrax
Summary
The US Food and Drug Administration’s Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical.
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