FDA Panel Sees Role For PK/PD Modeling In Revising Antibiotic “Breakpoints”
In certain circumstances it may be appropriate to change the criteria for determining when a pathogen is susceptible to a drug and recommended doses for systemic antibacterials absent clinical outcomes data, Anti-Infective Drugs Advisory Committee says.
You may also be interested in...
Anti-Infective Drugs Advisory Committee will meet Oct. 17 to discuss whether and when it is appropriate to base susceptibility test interpretive criteria on the highest or lowest approved dose of a drug, or whether labeling should reflect breakpoints specific to each approved dosing regimen and indication.
FDA plans to issue a yearly update on the susceptibility of bacteria to treatment by individual antibiotics and has drafted guidance that calls on drug makers to revise labeling for systemic antibacterial products accordingly
Manufacturers of antibiotics need to get involved as FDA writes clinical trial guidance for antibiotic drugs, according to Bruce Burlington, an independent consultant and former Wyeth VP