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Antibacterial Drugs: FDA Panel To Explore Approval Path For Single-Species Agents

 
• By Michael Cipriano

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.

The US FDA is calling on its Antimicrobial Drugs Advisory Committee to assess the potential use of five different development and regulatory pathways for antibacterial drugs targeting a single species of bacteria.

Sponsors have expressed interest in developing antibacterial drugs and monoclonal antibodies with activity against a single bacterial species that infrequently causes infection, but several hurdles exist in comparison with regular drug development, FDA said in

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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
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Recent and Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

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