
EMA Publishes Draft Guidance on Antibiotic Development
The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.
The European Medicines Agency (EMA) has published the third
The agency reports that the revised guidance reflects the outcome of
In addition, the guidance, adopted by EMA’s human medicines committee, offers clarification on the clinical development of antibacterial agents that are expected to address an unmet medical need in accordance with experience gained from previous regulatory decisions. Specific advice has also been added with regards to the EU regulatory requirements to develop medicines for the treatment of uncomplicated urinary tract infections and gonorrhea.
Comments should be submitted by July 31, 2019 to idwpecretariat@ema.europa.eu.
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