Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 40524 [2018-17527]
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Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
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Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17524 Filed 8–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[Docket No. FDA–2017–N–0809]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. 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
award of the priority review voucher.
FDA has determined that CRYSVITA
(burosamab-twza), manufactured by
Ultragenyx Pharmaceutical, Inc., meets
the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that CRYSVITA
(burosamab-twza), manufactured by
Ultragenyx Pharmaceutical, Inc., meets
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
[FR Doc. 2018–17527 Filed 8–14–18; 8:45 am]
Food and Drug Administration,
HHS.
ACTION:
the criteria for a priority review
voucher. CRYSVITA (burosamab-twza)
is indicated for the treatment of Xlinked hypophosphatemia in adult and
pediatric patients 1 year of age and
older.
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 https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about CRYSVITA
(burosumab-twza), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
VerDate Sep<11>2014
18:28 Aug 14, 2018
Jkt 244001
Food and Drug Administration
[Docket No. FDA–2018–D–0943]
Elemental Impurities in Animal Drug
Products—Questions and Answers;
Draft Guidance for Industry;
Availability; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; reopening
of the comment period.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
reopening the comment period for the
notice of availability that published in
the Federal Register on March 27, 2018.
In that document, FDA requested
comments on the draft guidance for
industry (GFI) #255 entitled ‘‘Elemental
Impurities in Animal Drug Products—
Questions and Answers.’’ The Agency is
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published March 27, 2018 (83 FR
13134). Submit either electronic or
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by October 15, 2018 to ensure that the
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SUMMARY:
PO 00000
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]]>Agencies
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Page 40524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0809]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. 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 award of the priority review voucher. FDA has determined
that CRYSVITA (burosamab-twza), manufactured by Ultragenyx
Pharmaceutical, Inc., meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
796-9856, email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
CRYSVITA (burosamab-twza), manufactured by Ultragenyx Pharmaceutical,
Inc., meets the criteria for a priority review voucher. CRYSVITA
(burosamab-twza) is indicated for the treatment of X-linked
hypophosphatemia in adult and pediatric patients 1 year of age and
older.
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 https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about CRYSVITA (burosumab-twza), go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17527 Filed 8-14-18; 8:45 am]
BILLING CODE 4164-01-P
