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2019-03-30
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Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
Notices
D09002ee1c172539a
D09002ee1c1725429
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. On July 13, 2018, FDA determined that TPOXX (tecovirimat), manufactured by SIGA Technologies, Inc., meets the criteria for a priority review voucher.
84 FR 12262
https://www.govinfo.gov/app/details/FR-2019-04-01/2019-06145
2019-06145
fr01ap19-85
4164-01-P
Docket No. FDA-2019-N-0895
https://www.govinfo.gov/app/details/FR-2019-04-01/2019-06145
https://www.govinfo.gov/content/pkg/FR-2019-04-01/html/2019-06145.htm
https://www.govinfo.gov/content/pkg/FR-2019-04-01/pdf/2019-06145.pdf
1 p.
12262
12262
84 FR 12262
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; Federal Register Vol. 84, Issue
NOTICE
2019-06145
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2019-N-0895
4164-01-P
2019-06145
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. On July 13, 2018, FDA determined that TPOXX (tecovirimat), manufactured by SIGA Technologies, Inc., meets the criteria for a priority review voucher.
Elizabeth Sadove, Office of Counterterrorism and Emerging Threats, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8510.
Issuance of Priority Review Voucher:
Material Threat Medical Countermeasure Product
,
https://www.accessdata.fda.gov/scripts/cder/daf/
https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm566498.htm#prv
Federal Register
Vol. 84, no. 62
Office of the Federal Register, National Archives and Records Administration
2019-04-01
continuing
daily
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444 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-04-01
P0b002ee1a02fe680
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr01ap19
https://www.govinfo.gov/app/details/FR-2019-04-01
https://www.govinfo.gov/content/pkg/FR-2019-04-01/pdf/FR-2019-04-01.pdf
https://www.govinfo.gov/content/pkg/FR-2019-04-01/xml/FR-2019-04-01.xml
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DGPO
2019-03-30
2023-10-10
FR-2019-04-01
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eng
FR
FR-2019-04-01
84
62