BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 1.02.2019

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices." This guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek 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.

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