2020-00936. Determination of Regulatory Review Period for Purposes of Patent Extension; MAVYRET  

Document Information

Published:
01/22/2020
Department:
Health and Human Services Department
Agency:
Food and Drug Administration
EntryType:
Notice
Action:
Notice.
Document Number:
2020-00936
Dates:
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by March 23, 2020. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 20, 2020. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Pages:
3694-3696 (3 pages)
Docket Numbers:
Docket Nos. FDA-2018-E-3053 and FDA-2018-E-4226
SectionNoes:
PDF File:
2020-00936.pdf