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FDA Guidance – Revising ANDA Labeling Following Revision of the RLD Labeling

by inpharmedia | Jan 24, 2024 | Guidances, Regulatory

FDA published a new guidance in support of Drug Competition Action Plan, named “Revising ANDA Labeling Following Revision of the RLD Labeling”, providing the recommendations to tentatively approved ANDAs to help facilitate final approval on the earliest lawful...

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FDA Guidance – Revising ANDA Labeling Following Revision of the RLD Labeling

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