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.
Original language | English (US) |
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Article number | 16013 |
Journal | npj Vaccines |
Volume | 1 |
DOIs | |
State | Published - Aug 25 2016 |
ASJC Scopus subject areas
- Immunology
- Pharmacology
- Infectious Diseases
- Pharmacology (medical)