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Focus on Regulation

Tag Archives: CDER

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.”  This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order