On December 13, 2017, the U.S. Food and Drug Administration (FDA) published the final guidance for industry entitled “Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs Guidance for Industry.” The guidance provides recommendations on fulfilling the new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial and antifungal drugs as established by section 3044 of the 21st Century Cures Act (“Cures Act”). This provision added section 511A of the Food, Drug, and Cosmetic Act (FD&C Act), which requires FDA to establish a dedicated Interpretive Criteria Website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards and interpretive criteria. FDA established the Interpretive Criteria Website on December 13, 2017.
Within one year of the website being established, holders of approved applications whose drug product is listed on the website must remove the susceptibility test interpretive criteria information and related information from approved labeling and replace it with a reference to the Interpretive Criteria Website. The labeling changes required under section 511A(d)(1) of the FD&C Act apply to all applications, including ANDA(s). Therefore, these changes should be implemented within the specified time period referenced above for your ANDA(s) even if such updates are not already reflected in the last approved labeling for the respective reference listed drug.
Further, all applications covering systemic antibacterial and antifungal drugs approved on or after the date of establishment of the Interpretive Criteria Website must include in labeling a reference to the Interpretive Criteria Website in lieu of susceptibility test interpretive criteria and related information. Therefore, these changes should be reflected in the proposed labeling contained in your pending ANDA(s) even if such updates are not already reflected in the last approved labeling for the respective reference listed drug.
Please review the Cures Act and associated FDA Guidance, as referenced above, to determine if this new requirement applies to your pending and/or approved application(s) and submit changes, as appropriate.