Antibiotic Trial Standards To Be Revised By FDA Under Congressional Mandate
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
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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.
FDA Panel To Discuss “Breakpoint” Changes For Systemic Antibiotics
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.
CAP Drugs Must Meet Stricter Noninferiority Criteria Under Draft FDA Guidance
Biopharma firms developing drugs to treat community acquired pneumonia would be wise to follow the specifications FDA has set forth in a new 1draft guidance on the subject. The guidance specifies strict criteria for patient selection and confirmation of infection to support an evaluation based on noninferiority margins