Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications; Correction, 83097 [2020-28081]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflict of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–28054 Filed 12–18–20; 8:45 am]
In the
Federal Register of October 9, 2020 (85
FR 64150), in FR Doc. 2020–22403, the
following correction is made:
On page 64150, in the table, the entry
for ANDA 077788 is removed.
SUPPLEMENTARY INFORMATION:
Dated: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–28081 Filed 12–18–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
BILLING CODE 4164–01–P
[Docket No. FDA–2020–N–0001]
Scientific and Ethical Considerations
for the Inclusion of Pregnant Women in
Clinical Trials; Public Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
[Docket No. FDA–2020–N–1866]
ACTION:
Wockhardt Ltd., et al.; Withdrawal of
Approval of Nine Abbreviated New
Drug Applications; Correction
The Food and Drug
Administration (FDA, Agency, or we) is
announcing a public meeting that will
be convened by Duke University’s
Robert J. Margolis Center for Health
Policy and supported by a cooperative
agreement with FDA. The meeting,
entitled ‘‘Scientific and Ethical
Considerations for the Inclusion of
Pregnant Women in Clinical Trials,’’ is
intended to gather industry, patient,
clinician, researcher, institutional
review board, ethicist, professional
society and other stakeholder input on
the scientific and ethical issues that
surround the inclusion of pregnant
women in clinical trials for drug
development.
DATES: The public meeting will be held
on February 2, 2021, from 12 p.m. to 4
p.m. Eastern Time and February 3, 2021,
from 12 p.m. to 3 p.m. Eastern Time.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: The public meeting will be
a Zoom virtual meeting.
FOR FURTHER INFORMATION CONTACT:
Jasmine Smith, Office of New Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, at
ONDPublicMTGSupport@fda.hhs.gov or
301–796–0621; or Catherine Sewell,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5360, Silver Spring,
MD 20993–0002, Fax: 301–796–9897.
SUPPLEMENTARY INFORMATION:
AGENCY:
SUMMARY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Wockhardt Ltd., et al.;
Withdrawal of Approval of Nine
Abbreviated New Drug Applications’’
that appeared in the Federal Register on
October 9, 2020. The document
announced the withdrawal of approval
(as of November 9, 2020) of nine
abbreviated new drug applications
(ANDAs) from multiple applicants. The
document indicated that FDA was
withdrawing approval of the following
ANDA after receiving a withdrawal
request from VistaPharm, Inc., 7265
Ulmerton Rd., Largo, FL 33771: ANDA
077788, Albuterol Sulfate Syrup,
Equivalent to 2 milligrams base/5
milliliters. Before FDA withdrew the
approval of this ANDA, VistaPharm,
Inc., informed FDA that it did not want
the approval of the ANDA withdrawn.
Because VistaPharm, Inc., timely
requested that approval of this ANDA
not be withdrawn, the approval of
ANDA 077788 is still in effect.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUMMARY:
VerDate Sep<11>2014
22:33 Dec 18, 2020
Jkt 253001
Notice of public meeting.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
83097
I. Background
FDA endorses an informed and
balanced approach to gathering data
informing the safe and effective use of
drugs and biological products in
pregnancy through judicious inclusion
of pregnant women in clinical trials and
careful attention to potential fetal risk.
Input from this meeting will help
provide information on the
development of therapies for pregnancyspecific conditions and for general
medical conditions that occur in women
of childbearing age and who require
treatment during pregnancy. This
meeting supports the objectives of The
Task Force on Research Specific to
Pregnant Women and Lactating Women,
which was established by section 2041
of the 21st Century Cures Act (Pub. L.
114–255), to provide advice and
guidance on activities related to
identifying and addressing gaps in
knowledge and research on safe and
effective therapies for pregnant women
and lactating women, including the
development of such therapies and the
collaboration on and coordination of
such activities.1 Input from this meeting
may also help further inform the
finalization of FDA’s draft guidance
entitled ‘‘Pregnant Women: Scientific
and Ethical Considerations for Inclusion
in Clinical Trials’’ (https://www.fda.gov/
media/112195/download, also see 83 FR
15161 (April 9, 2018)).
II. Topics for Discussion at the Public
Meeting
The meeting will allow participants
(including industry, clinicians, patients,
researchers, institutional review boards,
ethicists, professional societies and
other stakeholders) to provide input on
key topics, including:
• Key areas of unmet needs for
therapeutic development or clinical data
in obstetrics
• The regulatory, scientific, and
ethical considerations and challenges in
the enrollment of pregnant women in
clinical research
For more information on the meeting
topics and discussion questions, visit
https://healthpolicy.duke.edu/events/
scientific-and-ethical-considerationsinclusion-pregnant-women-clinicaltrials. FDA will publish a discussion
guide outlining background information
on the topic areas to this website
approximately 2 weeks before the
meeting date. FDA will also post the
agenda and other meeting materials to
this website approximately 5 business
days before the meeting.
1 https://www.nichd.nih.gov/sites/default/files/
2018-09/PRGLAC_Report.pdf.
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Page 83097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28081]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1866]
Wockhardt Ltd., et al.; Withdrawal of Approval of Nine
Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
entitled ``Wockhardt Ltd., et al.; Withdrawal of Approval of Nine
Abbreviated New Drug Applications'' that appeared in the Federal
Register on October 9, 2020. The document announced the withdrawal of
approval (as of November 9, 2020) of nine abbreviated new drug
applications (ANDAs) from multiple applicants. The document indicated
that FDA was withdrawing approval of the following ANDA after receiving
a withdrawal request from VistaPharm, Inc., 7265 Ulmerton Rd., Largo,
FL 33771: ANDA 077788, Albuterol Sulfate Syrup, Equivalent to 2
milligrams base/5 milliliters. Before FDA withdrew the approval of this
ANDA, VistaPharm, Inc., informed FDA that it did not want the approval
of the ANDA withdrawn. Because VistaPharm, Inc., timely requested that
approval of this ANDA not be withdrawn, the approval of ANDA 077788 is
still in effect.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of October 9, 2020
(85 FR 64150), in FR Doc. 2020-22403, the following correction is made:
On page 64150, in the table, the entry for ANDA 077788 is removed.
Dated: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28081 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P
