FDA: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

The purpose of this guidance is to inform industry of how the FDA intends to comply with section 1111 of the Food and Drug Administration Amendments Act (FDAAA), which requires FDA to identify and periodically update susceptibility test interpretive criteria2 for antibacterial drug products and to make those findings publicly available.

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