UPCOMING MEETINGS
|
DATE: September 14-17, 2011
TIME: 8:00 a.m. to 5:00 p.m.
LOCATION: Hyatt Regency Washington on Capitol Hill, 400 New Jersey
Ave NW, Washington, DC 20001-2097
This meeting will provide a forum to focus on the scientific and
regulatory issues regarding the use of allergenic products to diagnosis and
treat allergic diseases, as well as the impact of these issues on specialty
practice and in the clinical setting.
DATE: September 16, 2011
TIME: 8:30 a.m. to 5:00 p.m.
LOCATION: Silver Spring Hilton Hotel, 8727 Colesville Rd, Silver
Spring , MD, 20910
The purpose of the meeting is to encourage public comment on the
recommendations proposed in the Institute of Medicine (IOM) report.
DATE: September 16, 2011
TIME: 8:00 a.m. to 5:30 p.m.
LOCATION: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877
The purpose of the public workshop is to identify and discuss the key
issues related to the development and evaluation of next-generation smallpox
vaccines. The public workshop will include presentations on the human response
to smallpox vaccines and development of animal models for demonstration of
effectiveness of next-generation smallpox vaccines.
DATE: September 22, 2011
TIME: 8:00 a.m. to 12:00 p.m.
LOCATION: The Embassy Suites Hotel, San Francisco Airport, 250
Gateway Boulevard, South San Francisco, CA 94080
The objective of this Town Hall meeting is to engage in a dialogue
about issues that are of importance to the public.
DATE: September 22-23, 2011
TIME: 8:00 a.m. to 5:30 p.m.
LOCATION: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877
On Thursday, September 22, 2011, the committee will discuss Fluarix
(influenza virus vaccine), Afluria (influenza virus vaccine), and Abilify
(aripiprazole). There will also be an update on a study jointly funded by the
Agency for Healthcare Research and Quality (AHRQ) and FDA on antipsychotic use
and metabolic effects in children.
On Friday, September 23, 2011, the committee will discuss Akten
(lidocaine hydrochloride), Famvir (famciclovir), Levaquin (levofloxacin),
Navstel (balanced salt ophthalmic solution with hypromellose, dextrose, and
glutathione), Retrovir (zidovudine), Topamax (topiramate), Triesence
(triamcinolone acetonide injectable suspension), Videx EC (didanosine), Ziagen
(abacavir sulfate), and Zomig Nasal Spray (zolmitriptan). There will be an
informational update on Kaletra (lopinavir/ritonavir) oral solution and
tablets.
DATE: September 22-23, 2011
TIME: 8:00 a.m. to 5:00 p.m.
LOCATION: Hilton Hotel Washington DC North/Gaithersburg, 620 Perry
Parkway, Gaithersburg, MD 20977
On September 22, 2011, the committee will discuss BLA 125397,
Umbilical Cord Blood, New York Blood Center, indicated for hematologic
malignancies, bone marrow failure, primary immunodeficiency diseases, beta
thalassemia, Hurler syndrome, Krabbe disease, and X-linked
adrenoleukodystrophy. On September 23, 2011, the committee will discuss HDE
BH110018, CliniMACS CD34 Selection System, Miltenyi Biotec, for processing
allogeneic HLA-matched hematopoietic progenitor cells-apheresis (HPC-C) from a
related donor to obtain a CD34+ cell population intended for hematopoietic
reconstitution following a myeloablative preparative regimen without the need
for additional graft-vs-host disease (GVHD) prophylaxis in patients with acute
myelogenous leukemia in first or second morphologic complete remission.
DATE: September 26, 2011
TIME: 8:30 a.m. to 4:30 p.m.
LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm.
1503), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993
This public workshop is intended to provide information for, and to
gain additional insight from, professional societies, patient advocates,
industry, consumer groups, health care professionals, researchers, and other
interested persons about the causes and impact of drug shortages, and possible
strategies for preventing or mitigating drug shortages. The input from this
public workshop will help in developing topics for further discussion with
industry and professional societies, and other stakeholders and may help the
Agency to better address drug shortage issues.
DATE: September 26-27, 2011
TIME: 8:30 a.m. to 4:30 p.m.
LOCATION: FDA White Oak Campus, Building 2, A-2031, 10903 New
Hampshire Avenue, Silver Spring, Maryland 20993
The purpose of the workshop/symposium is to facilitate medical device
innovation with the focus on tissue adhesive materials.
DATE: October 4-5, 2011
TIME: October 4, 8:00 a.m. to 5:30 p.m.; October 5th, 8:30 a.m. to
5:00 p.m.
LOCATION: Hyatt Dulles Hotel, 2300 Dulles Corner Blvd., Herndon,
Virginia
Stakeholders will develop priorities on the key issues with the
safety and effectiveness of medical device/system alarms.
DATE: October 13, 2011
TIME: 8:00 a.m. to 6:00 p.m.
LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm.
1503), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993
The purpose of the public meeting is to discuss performance
evaluation of highly multiplexed microbiology/medical countermeasure (MCM)
devices, their clinical application and public health/clinical needs, and
quality criteria for establishing the accuracy of reference databases .
DATE: October 14, 2011
TIME: 8:00 a.m. to 6:00 p.m.
LOCATION: Hilton Washington DC North/Gaithersburg, salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD 20977.
The committee will discuss the Progensa PCA3 assay sponsored by
Gen-Probe, Inc., indicated for use in conjunction with other patient
information to aid in the decision for repeat biopsy in men 50 years of age or
older who have had one or more previous negative prostate biopsies and for whom
a repeat biopsy would be recommended based on current standard of care, before
consideration of PCA3 assay results.
DATE: October 24, 2011
TIME: 9:00 a.m. to 5:00 p.m.
LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm.
1503), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993
The purpose of the public meeting is to a discuss proposed
recommendations for the reauthorization of the Prescription Drug User Fee Act
(PDUFA), which authorizes FDA to collect user fees and use them for the process
for the review
of human drug applications for fiscal years (FYs) 2013 through
2017.
DATE: October 31, 2011
TIME: 8:00 a.m. - 1:30 p.m.
LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm.
1503), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993
The aim of the conference is to further the public health mission of
the FDA through training, collaboration, and structured discussion between
health professional organizations and FDA staff.
Please visit FDA’s Advisory Committee page (http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm)
to obtain advisory committee meeting agendas, briefing materials, and meeting
rosters prior to the meetings. You may also visit this page after meetings to
obtain transcripts, presentations, and voting results. For additional
information on other agency meetings please visit Meetings, Conferences, &
Workshops (http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/default.htm).
|
 |
pellentesque. Ut mattis justo sit amet orci. Duis mollis pretium
pede. Integer facilisis. Sed vel eros. Nunc convallis tempus nisi. Sed aliquam
mattis elit Donec semper blandit massa
