Home » Endpoints, Trial Design for Skin Infection Drugs Are Focus of US FDA Draft Guidance
Endpoints, Trial Design for Skin Infection Drugs Are Focus of US FDA Draft Guidance
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while superiority trial designs are recommended for milder skin infection treatment candidates, according to an FDA draft guidance. The draft is intended to assist drugmakers in designing clinical trials for systemic treatments for ABSSIs and topical or systemic drugs for milder skin infections.
International Pharmaceutical Regulatory Monitor
International Pharmaceutical Regulatory Monitor
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