Data Integrity and Antibiotic Clinical Trials: FDA, Industry Try Systemic Therapy
This article was originally published in RPM Report
Executive Summary
FDA's push to encourage development of new antibiotics requires getting past data integrity issues in the class. The agency's workshop on antibacterial clinical trials revealed a range of efforts aimed at better Good Clinical Practices compliance - and those efforts can just as easily be applied to other drug classes
You may also be interested in...
FDA Catching Antibiotic Incentive Bug: Agency Primed To Consider Ways To Shorten Route for Resistant-Strain Drugs
FDA is working along a parallel path to other several other government agencies to find ways to stimulate drug development for anti-infectives active against resistant strains. Top policy leaders in the drug review divisions reflect the new interest by thinking aloud how historical controls or oncology-like accelerated approvals might speed the process.
Antibiotic Early Endpoints: FDA Looking At Patient Observations
An effort to identify early biomarkers of antibiotic efficacy is turning toward patient assessments of drug activity. FDA and industry scientists are both participating in the biomarker effort. The attention to patient observations reflects a growing interest at FDA.
FDA Catching Antibiotic Incentive Bug: Agency Primed To Consider Ways To Shorten Route for Resistant-Strain Drugs
FDA is working along a parallel path to other several other government agencies to find ways to stimulate drug development for anti-infectives active against resistant strains. Top policy leaders in the drug review divisions reflect the new interest by thinking aloud how historical controls or oncology-like accelerated approvals might speed the process.