Initially issued in draft in 2017, the document “Referencing Approved Drug Products in ANDA Submissions – Guidance for Industry” was issued in final today. It addresses the difference between the reference listed drug (RLD) (that must be cited as the basis of the ANDA submission) and the reference standard (RS), and provides details of how the terms are to be used and other useful information.
The Federal Register notice (here) announcing the document’s availability states, “This guidance is intended to address this confusion by explaining what these terms mean and by clarifying the differences among them. This guidance provides recommendations on how applicants can accurately use these terms in an ANDA, how persons can request FDA designation of an RLD, and how persons can request FDA selection of a reference standard.”
It also announces that “[T]he final guidance also explains that a controlled correspondence may be submitted to FDA instead of a citizen petition to request that FDA designate a different listed drug as an RLD,” which is a big change. I alert you to pay attention to the footnotes in the document as there is some important information contained therein. For instance, it may be the only place that instructs applicants that an authorized generic product may be used in a bioequivalence study if the actual RLD brand name is not available in the marketplace. While you may have known this, I believe this may be the only place where this tidbit is written in a guidance document (see Footnote 40 in the guidance). The full guidance can be found here.
