Microbiology Review

The Clinical Microbiology information is required only in NDAs for anti-infective drugs. Since these drugs affect microbial, rather than human physiology, reports on the drug's in vivo and in vitro effects on the target microorganisms are critical for establishing product effectiveness.

An NDA's Microbiology section usually includes data describing:

• the biochemical basis of the drug's action on microbial physiology;
• the drug's antimicrobial spectra, including results of in vitro preclinical studies demonstrating concentrations of the drug required for effective use;
• any known mechanisms of resistance to the drug, including results of any known epidemiologic studies demonstrating prevalence of resistance factors; and
• clinical microbiology laboratory methods needed to evaluate the effective use of the drug.

More specific guidance on developing the microbiology component of the NDA is available from the CDER's Guideline for the Format and Content of the Microbiology Section of an Application (February 1987).

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.