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Geschäft · 24.5.20231 Min. Lesezeit
Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG; Correction
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Zusammenfassung
The Food and Drug Administration (FDA or the Agency) is correcting a notice that appeared in the Federal Register of July 13, 2022. The document determined the regulatory review period for ENSPRYNG. After review of a timely request for reconsideration by the applicant of the calculation of the applicable regulatory review period of the biologic product ENSPRYNG in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →