Zdrowie i gospodarka · 17/09/2009

FDA Releases Draft Guidance on Microbiological Data for Systemic Antibacterial Drugs

The Food and Drug Administration (FDA) has released a draft guidance for the pharmaceutical industry on the requirements for microbiological data to support the development and approval of systemic antibacterial drugs. The guidance outlines the types of microbiological studies and assessments needed to support an investigational new drug application (IND) and a new drug application (NDA) for these products.