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New Drug Application 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