Home » FDA: Active Controls Advised for Antibacterial Drug Trials
FDA: Active Controls Advised for Antibacterial Drug Trials
September 1, 2010
Sponsors of antibacterial drug candidates to treat acute bacterial skin and skin structure infections (ABSSIs) should use either a noninferiority or superiority trial design, while
superiority trial designs are recommended for milder skin infection treatment candidates, according to an FDA draft guidance.