Restricted Experiments Guidance: Examples of Potential Restricted Experiments
Examples of experiments that involve the transfer of, or selection for, drug resistance traits include, but are not limited to:
- Alterations to the antibiotic target site (e.g., transpeptidase).
- Transfer of a genetic element that encodes for enzymes that inactivate antibiotics.
- Induction of efflux pumps responsible for the active transport of the antibiotic out of the bacterial cell.
- Introduction of genetic changes that decrease permeability of the bacterial cell wall to the antibiotic, etc.
These mechanisms of action may be induced through recombinant or synthetic technology or passive, step-wise selection pressure methods.
Page last reviewed: August 27, 2020, 01:35 PM
Content source: Division of Regulatory Science and Compliance