Increase In Antibacterial R&D Prompts EMA Proposal For Improved Guidance
Executive Summary
Following a resurgence of activity in the field of antibacterial products, the European Medicines Agency has proposed merging and updating its two existing guidelines on this topic into a single, clearer, core document.
You may also be interested in...
EMA Urged To Expand 'Unmet Needs' Definition To Support New Antibiotics
The European Medicines Agency should consider policies that would allow new antibacterial products for serious and life-threatening infections to qualify for an expedited review, the pharmaceutical industry has suggested.
EMA Consults On Extrapolation Considerations For Antibacterial Agents To Treat Pediatrics
Draft guidance from the European Medicines Agency explains what data companies should generate when they seek marketing approval for antibacterial agents for treating children, including whether pharmacokinetic data in a limited number of pediatric subjects may be suffice to grant a pediatric indication.
EU, US, Japan Further Align Clinical Trial Requirements For Certain New Antibiotics
To support the development of antibiotics, regulators from the EU, the US and Japan met for the third time in two years and agreed to further align their clinical trial requirements to study the effects of new drugs in certain indications. The initiative was launched in response to increasing global concerns over antimicrobial resistance and the lack of development of new antibiotics.