Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. 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 TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming a priority review voucher.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 239 (Wednesday, December 14, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Page 76490]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27138]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1262]
Notice of Approval of Product Under Voucher: Rare Pediatric
Disease Priority Review Voucher
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of approval of a product redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
Food and Drug Administration Safety and Innovation Act (FDASIA),
authorizes FDA to award priority review vouchers to sponsors of
approved rare pediatric disease product applications that meet certain
criteria. 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 TYVASO DPI
(treprostinil), approved May 23, 2022, meets the criteria for redeeming
a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394, email:
<a href="/cdn-cgi/l/email-protection#db98baafb3a9a2b5f597bebe9bbdbfbaf5b3b3a8f5bcb4ad"><span class="__cf_email__" data-cfemail="e9aa889d819b9087c7a58c8ca98f8d88c781819ac78e869f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is announcing the approval of a product
redeeming a rare pediatric disease priority review voucher. Under
section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by
FDASIA, FDA will report the issuance of rare pediatric disease priority
review vouchers and the approval of products for which a voucher was
redeemed. FDA has determined that the supplemental application for
TYVASO DPI (treprostinil), approved May 23, 2022, meets the redemption
criteria.
For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to <a href="https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm">https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm</a>. For further
information about TYVASO DPI (treprostinil), approved May 23, 2022, 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: December 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27138 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.