First vaccine approval under the FDA Animal Rule

David Beasley, Trevor L. Brasel, Jason Comer

Research output: Contribution to journalReview article

9 Citations (Scopus)

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 languageEnglish (US)
Article number16013
Journalnpj Vaccines
Volume1
DOIs
StatePublished - Aug 25 2016

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Licensure
Vaccines
United States Food and Drug Administration
Biothrax

ASJC Scopus subject areas

  • Pharmacology
  • Infectious Diseases
  • Immunology
  • Pharmacology (medical)

Cite this

First vaccine approval under the FDA Animal Rule. / Beasley, David; Brasel, Trevor L.; Comer, Jason.

In: npj Vaccines, Vol. 1, 16013, 25.08.2016.

Research output: Contribution to journalReview article

Beasley, David ; Brasel, Trevor L. ; Comer, Jason. / First vaccine approval under the FDA Animal Rule. In: npj Vaccines. 2016 ; Vol. 1.
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