Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 46956 [2019-19298]
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Federal Register / Vol. 84, No. 173 / Friday, September 6, 2019 / Notices
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INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
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and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4332, Silver Spring,
MD 20993–0002, 301–796–2250.
SUPPLEMENTARY INFORMATION:
The guidance represents the current
thinking of FDA on ‘‘Drugs for
Treatment of Partial Onset Seizures:
Full Extrapolation of Efficacy from
Adults to Pediatric Patients 2 Years of
Age and Older.’’ It does not establish
any rights for any person and is not
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Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
issuance of vouchers as well as the
approval of products redeeming a
voucher. FDA has determined that
RINVOQ (upadacitnib) approved August
16, 2019, meets the redemption criteria.
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: 301–796–9858,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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 RINVOQ
(upadacitnib) approved August 16,
2019, 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 https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about RINVOQ
(upadacitnib) approved August 16,
2019, go to the ‘‘Drugs@FDA’’ website at
https://www.accessdata.fda.gov/scripts/
cder/daf/.
[FR Doc. 2019–19291 Filed 9–5–19; 8:45 am]
Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
BILLING CODE 4164–01–P
[FR Doc. 2019–19298 Filed 9–5–19; 8:45 am]
BILLING CODE 4164–01–P
jspears on DSK3GMQ082PROD with NOTICES
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Drugs for Treatment of Partial Onset
Seizures: Full Extrapolation of Efficacy
from Adults to Pediatric Patients 2
Years of Age and Older.’’ The guidance
provides recommendations to sponsors
on the clinical development of drugs for
the treatment of POS in pediatric
patients. Specifically, this guidance
addresses FDA’s current thinking
regarding clinical development
programs that can support extrapolation
of the efficacy of drugs approved for the
treatment of POS in adults to pediatric
patients 2 years of age and older. All the
public comments received on the draft
guidance have been considered and the
guidance has been revised as
appropriate, along with editorial
changes. This guidance finalizes the
draft guidance issued on February 16,
2018 (83 FR 7057).
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
VerDate Sep<11>2014
16:53 Sep 05, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
[Docket No. FDA–2014–D–0223]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Notice.
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
SUMMARY:
PO 00000
Frm 00025
Fmt 4703
Humanitarian Device Exemption
Program; Guidance for Industry and
Food and Drug Administration Staff;
Availability
Sfmt 4703
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Humanitarian Device
Exemption Program.’’ This guidance
concerns the humanitarian device
exemption (HDE) program as a whole
and, among other topics, it explains the
criteria FDA considers to determine if
‘‘probable benefit’’ has been
demonstrated as part of the Agency’s
SUMMARY:
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[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Page 46956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19298]
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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 vouchers
as well as the approval of products redeeming a voucher. FDA has
determined that RINVOQ (upadacitnib) approved August 16, 2019, meets
the redemption criteria.
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-
796-9858, email: [email protected].
SUPPLEMENTARY INFORMATION: 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 RINVOQ
(upadacitnib) approved August 16, 2019, 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 https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about RINVOQ (upadacitnib) approved August 16, 2019, go to
the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19298 Filed 9-5-19; 8:45 am]
BILLING CODE 4164-01-P
