[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Pages 45646-45647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19044]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Design of Clinical Trials of Aerosolized Antimicrobials for the
Treatment of Cystic Fibrosis; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding scientific issues in clinical development of
aerosolized antimicrobials for the management and/or treatment of
patients with cystic fibrosis. Aerosolized antimicrobials are used to
treat chronic bacterial infection in the lungs and thus improve the
respiratory symptoms in patients with cystic fibrosis. This public
workshop is intended to provide information for and gain perspective
from health care providers, patients and patient advocacy
organizations, academia, and industry on various aspects of the design
of clinical trials of aerosolized antimicrobials in patients with
cystic fibrosis. The input from this public workshop will help in
developing topics for further discussion.
Dates and Times: The public workshop will be held on September 23,
2010, from 8:30 a.m. to 5:30 p.m. and on September 24, 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 number) to
[email protected] Persons without access to the Internet can call
301-796-1300 to register. Persons needing a sign language interpreter
or other special accommodations should notify Christine Moser or Lori
Benner (see Contact Persons) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding scientific considerations in the design of clinical trials of
aerosolized antimicrobials to treat chronic bacterial infection in the
lungs and thus improve the respiratory symptoms in patients with cystic
fibrosis. The development of clinical trial endpoints to establish
efficacy is a major challenge in the design of informative clinical
trials of aerosolized antimicrobials for the management and/or
treatment of patients with cystic fibrosis. The workshop will include
discussion of clinical trial endpoints to establish efficacy, such as
timing and definitions of pulmonary exacerbations, changes in the
results of pulmonary function testing, and changes on patient reported
outcome measures. An important consideration will be the evaluation of
new aerosolized antimicrobials in the context of approved aerosolized
antimicrobials on the basis of these or other efficacy endpoints. Other
issues in the design of clinical trials of aerosolized antimicrobials
include: The development of drug resistance and
[[Page 45647]]
other safety concerns, microbiologic testing such as sputum bacterial
density, the utility of in-vitro susceptibility testing, and the need
for pediatric use information.
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 http://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. Transcripts will also be available
on the Internet http://www.fda.gov/Drugs/NewsEvents/ucm205809.htm
approximately 45 days after the workshop.
Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19044 Filed 8-2-10; 8:45 am]
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