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Zdrowie i gospodarka · 16.09.2016

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

The Food and Drug Administration (FDA or Agency) is announcing a public workshop regarding "Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs)." This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of these products, such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. The input from this public workshop will also help in developing topics for future discussion.

Source: Federal Register — Food and Drug AdministrationOpen original release →