Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public Workshop, 37818-37819 [2010-15814]
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Federal Register / Vol. 75, No. 125 / Wednesday, June 30, 2010 / Notices
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Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Issues in the Design and Conduct of
Clinical Trials for Antibacterial Drug
Development; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop regarding scientific
issues in the design and conduct of
clinical trials for antibacterial drug
development. The public workshop is
intended to provide information for and
gain perspectives from health care
providers, researchers, academia,
industry, and regulators on various
aspects of design and conduct of clinical
trials for antibacterial drugs. The
workshop will focus on the design and
conduct of non-inferiority (NI) clinical
E:\FR\FM\30JNN1.SGM
30JNN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 75, No. 125 / Wednesday, June 30, 2010 / Notices
trials, which are often used in the
evaluation of the safety and efficacy of
a new antibacterial drug. The input from
this public workshop will help in
developing topics for further discussion.
Date and Time: The public workshop
will be held on August 2, 2010, from
8:30 a.m. to 5:30 p.m. and on August 3,
2010, from 8 a.m. to 4 p.m.
Location: The public workshop will
be held at the Crowne Plaza Hotel, 8777
Georgia Ave., Silver Spring, MD 20910.
Seating is limited and available only on
a first-come, first-served basis.
Contact Persons: Chris Moser or Lori
Benner, Center for Drug Evaluation and
Research, Food and Drug
Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave.,
Bldg. 22, rm. 6209, Silver Spring, MD
20993–0002, 301–796–1300.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited. Seating will be
available on a first-come, first-served
basis. To register electronically, e-mail
registration information (including
name, title, firm name, address,
telephone and fax numbers) to
abtrialworkshop@fda.hhs.gov. Persons
without access to the Internet can call
Chris Moser or Lori Benner at 301–796–
1300 to register (see Contact Persons).
Persons needing a sign language
interpreter or other special
accommodations should notify
Christine Moser or Lori Benner at least
7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding scientific issues in the design
and conduct of clinical trials for
antibacterial drug development.
Over the past decade, there have been
public discussions on NI clinical trial
design and the types of infectious
disease indications for which the NI
clinical trial design is appropriate. This
public workshop will provide
information on NI trial design,
approaches to the justification of NI
margins, and the assessment and timing
of efficacy endpoints. Challenges in the
conduct of clinical trials will be
discussed, including good clinical
practice and quality system approaches.
The workshop will include
presentations and perspectives from
FDA and from stakeholders involved in
clinical research. The public workshop
is intended to provide information for
and gain perspective from health care
providers, researchers, academia,
industry, and regulators on various
aspects of the design and conduct of
clinical trials for antibacterial drug
development. The input from this
VerDate Mar<15>2010
16:53 Jun 29, 2010
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public workshop will help in
developing topics for further discussion.
The agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://www.
regulations.gov. It may be viewed at the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD. A transcript will also be available
in either hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
(HFI–35), Office of Management
Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–15814 Filed 6–29–10; 8:45 am]
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37819
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Richard A. Spires,
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Agencies
[Federal Register Volume 75, Number 125 (Wednesday, June 30, 2010)]
[Notices]
[Pages 37818-37819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Issues in the Design and Conduct of Clinical Trials for
Antibacterial Drug Development; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding scientific issues in the design and conduct of
clinical trials for antibacterial drug development. The public workshop
is intended to provide information for and gain perspectives from
health care providers, researchers, academia, industry, and regulators
on various aspects of design and conduct of clinical trials for
antibacterial drugs. The workshop will focus on the design and conduct
of non-inferiority (NI) clinical
[[Page 37819]]
trials, which are often used in the evaluation of the safety and
efficacy of a new antibacterial drug. The input from this public
workshop will help in developing topics for further discussion.
Date and Time: The public workshop will be held on August 2, 2010,
from 8:30 a.m. to 5:30 p.m. and on August 3, 2010, from 8 a.m. to 4
p.m.
Location: The public workshop will be held at the Crowne Plaza
Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited
and available only on a first-come, first-served basis.
Contact Persons: Chris Moser or Lori Benner, Center for Drug
Evaluation and Research, Food and Drug Administration, Office of
Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209,
Silver Spring, MD 20993-0002, 301-796-1300.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early because space is
limited. Seating will be available on a first-come, first-served basis.
To register electronically, e-mail registration information (including
name, title, firm name, address, telephone and fax numbers) to
abtrialworkshop@fda.hhs.gov. Persons without access to the Internet can
call Chris Moser or Lori Benner at 301-796-1300 to register (see
Contact Persons). Persons needing a sign language interpreter or other
special accommodations should notify Christine Moser or Lori Benner at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding scientific issues in the design and conduct of clinical
trials for antibacterial drug development.
Over the past decade, there have been public discussions on NI
clinical trial design and the types of infectious disease indications
for which the NI clinical trial design is appropriate. This public
workshop will provide information on NI trial design, approaches to the
justification of NI margins, and the assessment and timing of efficacy
endpoints. Challenges in the conduct of clinical trials will be
discussed, including good clinical practice and quality system
approaches.
The workshop will include presentations and perspectives from FDA
and from stakeholders involved in clinical research. The public
workshop is intended to provide information for and gain perspective
from health care providers, researchers, academia, industry, and
regulators on various aspects of the design and conduct of clinical
trials for antibacterial drug development. The input from this public
workshop will help in developing topics for further discussion.
The agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15814 Filed 6-29-10; 8:45 am]
BILLING CODE 4160-01-S