Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984–2018: an evaluation of Food and Drug Administration flexibilities

Review of 1065 new drug approvals by the FDA between 1984 and 2018, including 178 antimicrobial products, found a lower median time from investigational new drug application to approval for antimicrobials than non-antimicrobials (5.9 years vs 7.6 years, p<0.001).


The Lancet Infectious Diseases