USA – FDA clarifies reference-listed drugs, other ANDA terms in final guidance

Generic drugmakers have received finalized guidance from the US Food and Drug Administration. In finalizing a 2017 draft, the agency gives sponsors of abbreviated new drug applications (ANDAs) information about how to identify reference listed drugs (RLDs), further details on reference standards, and what forms the basis for an ANDA submission.
 
“The guidance is intended to clarify what these terms mean and how to accurately use these terms in an ANDA,” said FDA in announcing the availability of the guidance, which is a component in the agency’s Drug Competition Action Plan, a set of initiatives meant to spur increased availability of affordably priced medications.  
 
In clarifying how to identify the basis of submission and reference standard, as well as how to identify RLDs, FDA acknowledged in the Federal Register announcement of the guidance’s availability that “A variety of factors has led to confusion among stakeholders on what these terms mean and how an ANDA applicant should use them.”…