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BioWorld - Wednesday, May 27, 2026
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Home » US FDA proposes updates to 21-year-old ANDA labeling guidance
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US FDA proposes updates to 21-year-old ANDA labeling guidance

Jan. 25, 2022
By Mari Serebrov
More than three years after tossing a controversial proposal to allow manufacturers of generic drugs to update their labeling independent of the reference list drug (RLD) and promises that it would take a more proactive role in identifying and facilitating labeling updates, the U.S. FDA issued a draft guidance Jan. 25 intended to help holders of abbreviated new drug applications (ANDAs) keep their labels up to date with that of the RLD.
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