Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 19150 [2023-06593]
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Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices
of the statutory provision, which is
March 29, 2023. Although this policy is
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‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
Premarket notification ................................................................
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De Novo classification process ..................................................
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Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
award of the priority review voucher.
FDA has determined that DAYBUE
(trofinetide), approved March 10, 2023,
and manufactured by Acadia
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
[FR Doc. 2023–06646 Filed 3–29–23; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
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Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
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https://www.regulations.gov, https://
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Persons unable to download an
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Medical Devices: Premarket Submission
Considerations for Cyber Devices and
Related Systems Under Section 524B of
VerDate Sep<11>2014
17:22 Mar 29, 2023
Jkt 259001
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 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 DAYBUE
(trofinetide), manufactured by Acadia
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher. DAYBUE
(trofinetide) solution is for the treatment
of Rett Syndrome in adults and
pediatric patients 2 years of age and
older.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00100
Fmt 4703
Sfmt 4703
0910–0120
0910–0231
0910–0332
0910–0844
0910–0756
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 DAYBUE
(trofinetide), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06593 Filed 3–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–0266]
Identification of Medicinal Products—
Implementation and Use; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\30MRN1.SGM
Notice of availability.
30MRN1
]]>Agencies
[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Notices]
[Page 19150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0026]
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 DAYBUE (trofinetide), approved March 10, 2023, and manufactured by
Acadia Pharmaceuticals, Inc., meets the criteria for 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:
[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 DAYBUE
(trofinetide), manufactured by Acadia Pharmaceuticals, Inc., meets the
criteria for a priority review voucher. DAYBUE (trofinetide) solution
is for the treatment of Rett Syndrome in adults and pediatric patients
2 years 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 DAYBUE (trofinetide), go to the ``[email protected]'' website
at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06593 Filed 3-29-23; 8:45 am]
BILLING CODE 4164-01-P
