FDA Updates Orange Book to Clarify Difference Between RLDs and Reference Standards

January 31, 2017

The FDA has updated its Orange Book of approved drug products, clarifying which search results are reference listed drugs and which are reference standards. Both the print and online editions also make clear which products categorized under the book’s section on discontinued drugs may be referred to as an RLD.

The changes make it easier for applicants submitting ANDAs to delineate previously approved drugs from reference standards, which applicants must use in bioequivalence studies. The agency said sponsors often conflate the two, and refer to them interchangeably in ANDAs.

The FDA issued the update after publishing a draft guidance clarifying the terms last week. The agency also said it would not wait for the Federal Register to publish a determination that a reference listed drug’s removal from the market had nothing to do with safety and effectiveness.

Previously, the FDA would publish its findings that a drug was removed from the market for reasons other than its safety and effectiveness before it approved any related ANDAs.

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