Dual Antimicrobial-Testing Development Outlined in Guidance

The FDA is providing guidance for devicemakers that want to coordinate development of antimicrobial susceptibility tests with sponsors developing antimicrobial drugs.

Coordinated development of antimicrobial drugs and antimicrobial susceptibility tests (ASTs) should not be construed as companion diagnostics, the FDA said in the draft guidance.

Rather, the guidance describes interactions between devicemakers and drug sponsors to coordinat development, as well as explaining considerations for submitting separate applications to CDRH and CDER. — Tamra Sami