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.”
The new guidance is meant to provide clarity about the differences between the terms, and give clear recommendations about how each term should be used in an ANDA. Factors contributing to the confusion include the fact that many approved drug products have been discontinued, as well as how reference standards have been identified in the Orange Book.
The final version of the guidance includes some clarifications based on comments received on the draft guidance, with no substantive changes from that document. The final guidance does clarify that when an applicant wishes to have a different listed drug be designated an RLD, that request may be submitted by means of a controlled correspondence, rather than a citizen petition. (RELATED: FDA draft guidance looks to help speed new generics to market, Regulatory Focus 13 January 2017)
Appended to the guidance is a quick reference document defining terms and giving a bullet point summary of the concepts addressed in the guidance.
FDA