Determination of Regulatory Review Period for Purposes of Patent Extension; ORSERDU
Commenting Details

Comment by Nov. 16, 2024

Posted on Sept. 16, 2024

Agency FDA

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comments last updated: September 16, 2024

In the Weeds

Document ID FDA-2023-E-3224-0007

Federal Register ID 2024-20893

Docket ID FDA-2023-E-3224

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Summary

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for ORSERDU and is publishing this