Antibacterial Development: Industry Cautious About Role Of Animal Models
Payers and prescribers, not just the US FDA, need to understand the basis of approval, John Rex says.
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US FDA's Antimicrobial Head Ed Cox Leaves For Regeneron; Agency Needs New LPAD Champion
Long-time deputy John Farley becomes acting director of the Office of Antimicrobial Products. Cox, who served as the director of the office for more than a decade, joins Regeneron to serve as vice president of regulatory affairs.
Flexible 'Menu' Of Antibacterial Development Options Suggested By US FDA Panel
FDA should consider allowing sponsors in challenging area of single species antibacterials more flexibility in study designs, advisory committee suggests, despite disagreement over approaches such as animal models and non-inferiority trials.
Antibacterial Drugs: FDA Panel To Explore Approval Path For Single-Species Agents
US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.