The labeling for approved antifungal and antimicrobial prescription drug products contains certain language regarding the susceptibility test interpretive criteria (STIC) and associated test methods and quality control standards, with associated references for antimicrobial drugs for the specific compound. Many approved drug products have been around for a long time and the information regarding the STIC in their labels are outdated. One of the provisions of the 21st Century Cures Act required the FDA to act to assure that the STIC information contained in labeling for these products was up-to-date, and also required FDA to create a web page (here) that contained updated information on which criteria to include and which to remove.
The guidance describes the what, when, and how to update, add, or remove information in labeling, and advises that firms have one year from December 13, 2017 (the date of issuance of the guidance) to bring your labeling up to date.
This sounds ok for NDA products which can make such changes to their labeling on their own, but what about ANDAs whose labeling must be the same as that of the reference listed drug (RLD) referred to in their application? Not to worry, there are certain statutory provisions that permit ANDA holder to make certain changes in labeling from that of the RLD. For instance, changes can be made because the product is made by a different manufacturer, because of patent or exclusivity issues, or due to an approved ANDA suitability petition. However, there is a provision that permits ANDA applicants to make changes to comply with current FDA labeling guidelines or other guidance (21 CFR 314.94(a)(8)(iv)). The guidance goes on to note, “for ANDAs approved after the implementation of the Interpretive Criteria web page, if the ANDA holder submits proposed labeling changes to comply with the requirements of section 511A of the FD&C Act and the current RLD labeling does not include these labeling changes, FDA may consider such differences in labeling between the generic drug and RLD to be permissible differences in labeling under FDA’s authorities. See generally, sections 505(j)(2)(A) and 505(j)(4) of the FD&C Act and 21 CFR 314.94.” This permission also applies to ANDA supplements requesting STIC changes received after the establishment of the web page.
A full copy of the guidance can be found here . So, you better get going, as there are only 365 days to complete the required revisions. Please also tell your colleagues and friends at other firms, as this is one guidance with a relatively short fuse that could easily slip through the cracks without notice.