Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; PAXLOVID, 46139 [2024-11643]
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Federal Register / Vol. 89, No. 103 / Tuesday, May 28, 2024 / Notices
46139
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Centerfor Drug Evalmrlfun and Research
U.S ..Food and Drug-Administration
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2245]
Issuance of Priority Review Voucher;
Material Threat Medical
Countermeasure Product; PAXLOVID
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 material threat medical
countermeasure (MCM) product
application. The Federal Food, Drug,
and Cosmetic Act (FD&C Act) authorizes
FDA to award priority review vouchers
to sponsors of approved material threat
MCM product applications that meet
certain criteria. FDA is required to
publish notice of the award of the
priority review voucher. FDA has
determined that PAXLOVID
(nirmatrelvir co-packaged with
ritonavir) tablets, approved on May 25,
2023, manufactured by Pfizer, Inc.,
meets the criteria for a material threat
MCM 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,
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:43 May 24, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FDA is
announcing the issuance of a material
threat MCM priority review voucher to
the sponsor of an approved material
threat MCM product application. Under
section 565A of the FD&C Act (21 U.S.C.
360bbb–4a) FDA will award priority
review vouchers to sponsors of
approved material threat MCM product
applications that meet certain criteria
upon approval of those applications.
FDA has determined that PAXLOVID
(nirmatrelvir co-packaged with
ritonavir) tablets, manufactured by
Pfizer, Inc., meets the criteria for a
material threat MCM priority review
voucher. PAXLOVID was approved on
May 25, 2023, for the treatment of mildto-moderate coronavirus disease 2019
(COVID–19) in adults who are at high
risk for progression to severe COVID–19,
including hospitalization or death.
For further information about the
material threat MCM Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions#prv. For
further information about PAXLOVID
(nirmatrelvir co-packaged with
ritonavir) tablets go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
[FR Doc. 2024–11640 Filed 5–24–24; 8:45 am]
AGENCY:
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
Dated: May 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11643 Filed 5–24–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00085
Fmt 4703
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[Docket No. FDA–2024–N–2219]
Progynon Associates, et al.; Proposal
to Withdraw Approval of Four New
Drug Applications; Opportunity for a
Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of four new drug applications
(NDAs) and is announcing an
opportunity for the NDA holders to
request a hearing on this proposal. The
basis for the proposal is that the NDA
holders have repeatedly failed to file
required annual reports for those NDAs.
DATES: The NDA holders may submit a
request for a hearing by June 27, 2024.
Submit all data, information, and
analyses upon which the request for a
hearing relies July 29, 2024. Submit
electronic or written comments by July
29, 2024.
ADDRESSES: The request for a hearing
may be submitted by the NDA holders
by either of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
E:\FR\FM\28MYN1.SGM
28MYN1
EN28MY24.049</GPH>
Dated: May 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Notices]
[Page 46139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11643]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2245]
Issuance of Priority Review Voucher; Material Threat Medical
Countermeasure Product; PAXLOVID
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 material
threat medical countermeasure (MCM) product application. The Federal
Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award
priority review vouchers to sponsors of approved material threat MCM
product applications that meet certain criteria. FDA is required to
publish notice of the award of the priority review voucher. FDA has
determined that PAXLOVID (nirmatrelvir co-packaged with ritonavir)
tablets, approved on May 25, 2023, manufactured by Pfizer, Inc., meets
the criteria for a material threat MCM 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 material
threat MCM priority review voucher to the sponsor of an approved
material threat MCM product application. Under section 565A of the FD&C
Act (21 U.S.C. 360bbb-4a) FDA will award priority review vouchers to
sponsors of approved material threat MCM product applications that meet
certain criteria upon approval of those applications. FDA has
determined that PAXLOVID (nirmatrelvir co-packaged with ritonavir)
tablets, manufactured by Pfizer, Inc., meets the criteria for a
material threat MCM priority review voucher. PAXLOVID was approved on
May 25, 2023, for the treatment of mild-to-moderate coronavirus disease
2019 (COVID-19) in adults who are at high risk for progression to
severe COVID-19, including hospitalization or death.
For further information about the material threat MCM Priority
Review Voucher Program and for a link to the full text of section 565A
of the FD&C Act, go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv. For further information about
PAXLOVID (nirmatrelvir co-packaged with ritonavir) tablets go to the
``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: May 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11643 Filed 5-24-24; 8:45 am]
BILLING CODE 4164-01-P
