Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
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Issuing agencies
Abstract
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. FDA has determined that VEKLURY (remdesivir), manufactured by Gilead Sciences, Inc., meets the criteria for a material threat MCM priority review voucher.
Full Text
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<title>Federal Register, Volume 87 Issue 83 (Friday, April 29, 2022)</title>
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[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Page 25491]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09233]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0895]
Issuance of Priority Review Voucher; Material Threat Medical
Countermeasure Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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. FDA has determined that VEKLURY
(remdesivir), manufactured by Gilead Sciences, Inc., meets the criteria
for a material threat MCM priority review voucher.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 301-796-8515, Fax: 301-796-8615, email:
<a href="/cdn-cgi/l/email-protection#cd88988ce3828e88998daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="eaafbfabc4a5a9afbeaa8c8e8bc4828299c48d859c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a material
threat MCM priority review voucher to the sponsor of an approved
material threat MCM product application. Under section 565A of the FD&C
Act (21 U.S.C. 360bbb-4a), which was added by the Cures Act (Pub. L.
114-255), FDA will award priority review vouchers to sponsors of
approved material threat MCM product applications that meet certain
criteria upon approval of those applications. FDA has determined that
VEKLURY, manufactured by Gilead Sciences, Inc., meets the criteria for
a material threat MCM priority review voucher. Remdesivir was approved
on October 22, 2020, for use in adult and pediatric patients 12 years
of age and older and weighing at least 40 kilograms (about 88 pounds)
for the treatment of COVID-19 requiring hospitalization.
For further information about the material threat MCM Priority
Review Voucher Program and for a link to the full text of section 565A
of the FD&C Act, go to <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation</a>. For further information about VEKLURY, go
to the ``Drugs@FDA'' website at <a href="https://www.accessdata.fda.gov/scripts/cder/daf/">https://www.accessdata.fda.gov/scripts/cder/daf/</a>.
Dated: April 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09233 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P
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