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See today's BioWorld Asia
Home » EMA tackles AMR with revised guidance
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EMA tackles AMR with revised guidance

May 31, 2022
By Mari Serebrov
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
BioWorld Asia Regulatory Infection Antibiotic Europe EMA

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