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# Agencies to Harmonize Antibacterial Study Requirements
- URL: https://www.fdaweb.com/agencies-to-harmonize-antibacterial-study-requirements/
- Published: 2017-05-30T12:00:00.000Z
- Updated: 2026-09-14T22:26:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138803

Officials of FDA, the European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency agreed at a 4/26-4/27 meeting that some requirements for clinical studies for antibacterial agents for specific types of infections such as urinary and intra-abdominal infections could be harmonized. A meeting [summary](http://www.ema.europa.eu/ema/index.jsp?curl=pages/news%5Fand%5Fevents/events/2017/05/event%5Fdetail%5F001449.jsp&mid=WC0b01ac058004d5c3&ref=fdaweb.com) says participants discussed differences in the agencies’ regulatory approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.

They discussed and defined pathways agreeable to the three agencies for development of new antibacterial agents addressing unmet needs resulting from antimicrobial resistance, and agreed to hold further discussion in this context as well as other areas, the summary says.