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FDA Emphasizes Microbiology Data in Antibacterial Drug Development

August 29, 2016

The FDA is providing drugmakers with a roadmap on the clinical development of investigational antibacterial drugs.

In a final guidance released Thursday, the FDA reprioritizes its advice on general approaches to microbiology data collection for antibacterial drugs, bringing it to the forefront of the document.

Specific recommendations on data presentation and labeling have been moved to the appendix of the document in the latest version. The FDA said the restructuring of the document follows industry comments on the draft version issued in September 2009.

The recommendations in the latest guidance remain virtually unchanged. For instance, the FDA continues to advise sponsors to evaluate product activity against a test panel of relevant bacteria in the intended indication. The new document, however, provides a suggested number of bacteria tests.

The FDA says at least 300 or more species of the bacteria Enterobacteriaceae should be tested. For the rest of the bacteria, such as Pseudomonas aeruginosa or Neisseria gonorrhoeae, the agency expects studies of at least 100 species.

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