Drug Makers Face Higher Relabeling Burden For Antibacterial Resistance Info
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
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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.
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 demonstrated a willingness to be flexible about antibiotic breakpoints in its Oct. 29 approval of Forest Laboratories' ceftaroline fosamil.