Office of Infectious Diseases (OID) - Division of Anti-Infectives (DAI)

The Division of Anti-Infectives (DAI) regulates and reviews Investigational New Drug (IND) applications and marketing applications for drug products intended for the prevention or treatment of infectious diseases caused by bacteria, fungi, or parasites.

The DAI leads the work on establishing and recognizing susceptibility test interpretive criteria (STIC) or breakpoints for antibacterial and antifungal drugs (see here for more details: https://www.fda.gov/STIC).

Resources:

• Information for Pre-IND Submissions
• Expanded Access Programs
• FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
• FDA Response to Antimicrobial Resistance
• Tropical Disease Priority Review Voucher Program
• OID Research Activities
• Guidances: For DAI specific and/or relevant guidance documents (draft or final)
• Advisory Committee Meetings: Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)
• Public Meetings (Upcoming and Past)