Second Revision of FDA Guidance Microbiology Data for Systemic Antibacterial Drugs

In February, the FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation". The focus of that guidance document is on assisting sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. It replaces the guidance for industry "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation" issued in August 2016.

In the document the FDA defines their expectation on a microbiology development programme needed to support clinical development and approval of antibacterial drugs administered systemically as well as microbiology information collected after approval.

The current guideline covers the following topics:

I. INTRODUCTION
II. MICROBIOLOGY DEVELOPMENT PROGRAM
A. Early Development Nonclinical Considerations
1. Antibacterial Spectrum of Activity
2. Mechanism of Action
3. Intracellular Antimicrobial Concentration Assessment
4. Resistance Studies
B. In Vitro Antimicrobial Susceptibility Test Methods During Drug Development
1. Early Clinical Development
2. Provisional Antibacterial Susceptibility Test Interpretive Criteria
3. Establishing In Vitro Antibacterial Susceptibility Test Interpretive Criteria
4. Quality Control Parameters
C. Other Considerations
1. First and Second Lists of Target Bacteria in Labeling
2. Antibacterial Interactions and Fixed-Combination Studies
3. Additional Nonclinical Studies of Antibacterial Drugs
4. Animal Models of Infection
5. Microbiology Information Collected in Clinical Trials
6. Electronic Submission of Microbiology Information
7. Location of Microbiology Information
8. Postmarketing Microbiology Information

Additionally the following appendizes are part of the revised guideline:

  • APPENDIX A: GUIDELINES FOR BACTERIAL ISOLATE SELECTION FOR STUDIES OF IN VITRO ANTIBACTERIAL ACTIVITY
  • APPENDIX B: STUDY REPORTS OF SPECTRUM OF ACTIVITY AND RESISTANCE
  • APPENDIX C: DATABASE FOR FINAL IN VITRO ANTIBACTERIAL SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA
  • APPENDIX D: EXAMPLE FORMAT FOR SECTIONS OF LABELING THAT PERTAIN TO MICROBIOLOGY
  • APPENDIX E: INFORMATION REGARDING THE SECOND BACTERIA LIST IN THE MICROBIOLOGY SUBSECTION OF LABELING

This guidance addresses the types of microbiology information that should be provided to support an investigational new drug application (IND), a new drug application (INDA), a biologics license application (BLA), and a supplemental NDA or BLA. For more details see the full document "Microbiology Data for Systemic Antibacterial Drugs" 

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