Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 55011 [2022-19384]
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Federal Register / Vol. 87, No. 173 / Thursday, September 8, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Silver Spring, MD 20993, 301–796–
3473, Elimika.Fletcher@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘General Clinical Pharmacology
Considerations for Pediatric Studies of
Drugs, Including Biological Products.’’
Effectiveness, safety, or dose-finding
studies in pediatric patients involve
gathering clinical pharmacology
information, such as information
regarding a product’s pharmacokinetics
and pharmacodynamics, to inform dose
selection and individualization. This
draft guidance addresses general clinical
pharmacology considerations for
conducting studies so that the dosing
and safety information for drugs and
biological products in pediatric
populations can be sufficiently
characterized, leading to well-designed
trials to evaluate effectiveness.
In general, this draft guidance focuses
on the clinical pharmacology
information (e.g., exposure-response,
pharmacokinetics, and
pharmacodynamics) that supports
findings of effectiveness and safety and
helps identify appropriate doses in
pediatric populations. This draft
guidance also describes how
quantitative approaches (i.e.,
pharmacometrics) can use disease and
exposure-response knowledge from
relevant prior clinical studies to help
design and evaluate future pediatric
studies.
This draft guidance revises the draft
guidance, ‘‘General Clinical
Pharmacology Considerations for
Pediatric Studies of Drugs and
Biological Products,’’ issued on
December 9, 2014 (79 FR 73079). This
draft guidance provides clarification on
clinical pharmacology studies in
pediatric patients from the 2014 draft
guidance in response to public
comments.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘General Clinical Pharmacology
Considerations for Pediatric Studies of
Drugs and Biological Products.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved FDA collections of
information. These collections of
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information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information for the
submission of new drug applications in
21 CFR part 314 have been approved
under OMB control number 0910–0001.
The collections of information for the
submission of biologics license
applications in 21 CFR part 601 have
been approved under OMB control
number 0910–0338. The collections of
information for the submission of
investigational new drug applications in
21 CFR part 312 have been approved
under OMB control number 0910–0014.
The collections of information for the
protection of human subjects and
institutional review boards in parts 21
CFR parts 50 and 56 have been
approved under OMB control number
0910–0130. The collections of
information for the submission of
prescription drug product labeling in 21
CFR 201.56 and 201.57 have been
approved under OMB control number
0910–0572. The collections of
information in 21 CFR 312.47 and
312.82 for requesting meetings with
FDA about drug development programs
have been approved under OMB control
number 0910–0429.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19410 Filed 9–7–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
55011
Act (the 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 VABYSMO
(faricimab-svoa), for which a priority
review voucher was redeemed, was
approved January 28, 2022.
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: Cathryn.Lee@
fda.hhs.gov.
FDA is
announcing the approval of 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 VABYSMO (faricimabsvoa), approved January 28, 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 https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about VABYSMO (faricimab-svoa), go to
the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19384 Filed 9–7–22; 8:45 am]
BILLING CODE 4164–01–P
[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:
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
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National Institutes of Health
Office of the Secretary; Notice of
Meeting
Notice.
SUMMARY:
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Muscular Dystrophy
Coordinating Committee (MDCC).
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[Federal Register Volume 87, Number 173 (Thursday, September 8, 2022)]
[Notices]
[Page 55011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19384]
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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 product redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic Act (the 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 VABYSMO (faricimab-
svoa), for which a priority review voucher was redeemed, was approved
January 28, 2022.
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:
[email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the approval of 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 VABYSMO (faricimab-svoa), approved
January 28, 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 https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about VABYSMO (faricimab-svoa), go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19384 Filed 9-7-22; 8:45 am]
BILLING CODE 4164-01-P
