Drug Regulators, FDA, Publish Guidance For Systemic Antibaterial Agents
The purpose of this guidance is to inform industry of the Food and Drug Administration’s (FDA’s) current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product. This guidance is intended to serve as a focus for continued discussions among the Office of Antimicrobial Products, pharmaceutical sponsors and applicants, the academic community, and the public. Recommendations in this guidance cover three major areas: (1) conducting general nonclinical studies; (2) conducting animal and human studies and clinical trials; and (3) establishing and updating in vitro susceptibility test methods, quality control parameters, and interpretive criteria. This guidance also recommends the content and format for presentation of microbiological data for antibacterial drug products in the Microbiology subsection of labeling.
This guidance does not address the development of antiviral, antifungal, antiparasitic, or antimycobacterial agents or antibacterials administered by nonsystemic routes (e.g., topical). This guidance is not meant to provide details on clinical trial design.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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