Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher
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Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act, authorizes FDA to award priority review vouchers to sponsors of a material threat medical countermeasure application that meets certain criteria upon approval of such application. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for MOUNJARO (tirzepatide) injection, approved May 13, 2022, meets the redemption criteria.
Full Text
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<title>Federal Register, Volume 87 Issue 166 (Monday, August 29, 2022)</title>
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[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Page 52790]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18523]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0895]
Notice of Approval of Product Under Voucher: Material Threat
Medical Countermeasure Priority Review Voucher
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
approval of a product redeeming a priority review voucher. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century
Cures Act, authorizes FDA to award priority review vouchers to sponsors
of a material threat medical countermeasure application that meets
certain criteria upon approval of such application. FDA is required to
publish notice of the issuance of priority review vouchers as well as
the approval of products redeeming a priority review voucher. FDA has
determined that the application for MOUNJARO (tirzepatide) injection,
approved May 13, 2022, meets the redemption criteria.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8515
(this is not a toll-free number), email: <a href="/cdn-cgi/l/email-protection#6b2e3e2a4524282e3f2b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="793c2c3857363a3c2d391f1d185711110a571e160f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21
U.S.C. 360bbb-4a), which was added by section 3086 of the 21st Century
Cures Act (Pub. L. 114-255), FDA will report the issuance of material
threat medical countermeasure priority review vouchers and the approval
of products for which a voucher was redeemed. FDA has determined that
the application for MOUNJARO (tirzepatide) injection, approved May 13,
2022, meets the redemption criteria.
For further information about the Material Threat Medical
Countermeasure 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/21st-century-cures-act-mcm-related-cures-provisions">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions</a>. For
further information about MOUNJARO (tirzepatide) injection, 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: August 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18523 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P
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