|
|
October 9,
2009
October 8,
2009
October 7,
2009
October 6,
2009
|
|
|
October 9,
2009
-
-
Buprenorphine
Hydrochloride
Tablets,
Roxane
Laboratories,
Inc.,
Approval
-
CellCept
(mycophenolate
mofetil)
Capsules,
Roche
Palo
Alto,
LLC,
Labeling
Revision
-
CellCept
(mycophenolate
mofetil)
Tablets,
Roche
Palo
Alto,
LLC,
Labeling
Revision
-
CellCept
(mycophenolate
mofetil
hydrochloride)
Injection,
Roche
Palo
Alto,
LLC,
Labeling
Revision
-
CellCept
(mycophenolate
mofetil)
Oral
Suspension,
Roche
Palo
Alto,
LLC,
Labeling
Revision
-
Myfortic
(mycophenolic
acid)
Delayed-Release
Tablets,
Novartis
Pharmaceuticals
Corp.,
Labeling
Revision
-
Rapamune
(sirolimus)
Oral
Solution,
Wyeth
Pharmaceuticals,
Inc.,
Labeling
Revision
-
Rapamune
(sirolimus)
Tablets,
Wyeth
Pharmaceuticals,
Inc.,
Labeling
Revision
-
Sandimmune
(cyclosporine)
Injection,
Novartis
Pharmaceuticals
Corp.,
Labeling
Revision
-
Sandimmune
(cyclosporine)
Oral
Solution,
Novartis
Pharmaceuticals
Corp.,
Labeling
Revision
-
Sandimmune
(cyclosporine)
Capsules,
Novartis
Pharmaceuticals
Corp.,
Labeling
Revision
October 8,
2009
-
-
Cetirizine
Hydrochloride
Oral
Solution,
Amneal
Pharmaceuticals,
Approval
-
Kytril
(granisetron
hydrochloride)
Injection,
Hoffmann-La
Roche,
Inc.,
Labeling
Revision
-
Kytril
(granisetron
hydrochloride)
Oral
Solution,
Hoffmann-La
Roche,
Inc.,
Labeling
Revision
-
Kytril
(granisetron
hydrochloride)
Tablets,
Hoffmann-La
Roche,
Inc.,
Labeling
Revision
-
Polyethylene
Glycol
3350
Powder
for
Solution,
Nexgen
Pharma,
Inc.,
Approval
-
Viread
(tenofovir
disoproxil
fumarate)
Tablets,
GILEAD
SCIENCES,
INC.,
Efficacy
Supplement
|
|
|
-
DIA/FDA
Assessing
Benefits
and
Risks of
Medicinal
Products
in
Regulatory
Decisions,
November
3-5,
2009,
Hyatt
Regency
Bethesda,
One
Bethesda
Metro
Center,
Bethesda,
Maryland.
Meeting
information
and
registration
-
DIA/FDA/PhRMA
Modeling
and
Simulation
in Drug
Development:
Quantitative
Approaches
for
Decision
Making,
October
28-29,
2009,
Marriott
Bethesda
Pooks
Hill,
5151
Pooks
Hill
Road,
Bethesda,
Maryland.
Meeting
information
and
registration
-
CDER's
Small
Business
Assistance
Educational
Forum:
The
Investigational
New Drug
Process,
Public
Workshop,
October
15,
2009,
5100
Paint
Branch
Parkway,
College
Park, MD
20740.
Auditorium
1A003.
Meeting
information
and
registration
-
Preparation
for ICH
meetings
in St.
Louis,
Missouri
to
provide
information
and
receive
comments
on the
International
Conference
on
Harmonization
(ICH) as
well as
the
upcoming
meetings
in St.
Louis,
Missouri,
Public
Meeting,
October
14,
2009,
Washington
Room,
Hilton
Rockville,
1750
Rockville
Pike,
Rockville,
Maryland
-
DIA/FDA/NCI/PhRMA
Progression-Free
Survival
Oncology
Workshop,
October
7-9,
2009,
DoubleTree
Hotel
and
Executive
Meeting
Center,
8120
Wisconsin
Avenue,
Bethesda,
Maryland 20814.
Meeting
information
and
registration
-
CDER
Forum
for
International
Drug
Regulatory
Authorities,
October
5-9,
2009,
Silver
Spring,
Maryland.
|
|
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| |
|
|
|
- Berinert
Product Approval, Posted: 10/9/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Postdoctoral Fellowship (OBRR), Posted: 10/9/2009
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot release information, Updated: 10/7/2009
- Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 10/7/2009
- 2009 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee
10/9/2009 meeting materials update, Updated: 10/7/2009
- COBAS TaqScreen MPX Test
Updated Package Insert, Posted: 10/6/2009
- Havrix
Updated Package Insert, Posted: 10/6/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Senior Quality Assurance Specialist (OVRR/DPQ/QAS), Posted: 10/6/2009
- Avioq HIV-1 Microelisa System
Product Approval, Posted: 10/5/2009
|
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| |
|
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|
October 9,
2009
October 8,
2009
October 7,
2009
October 6,
2009
October 5,
2009
|
|
|
- FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, June 1-2, 2009
- FDA Workshop: Implementation of Post Approval Studies for Medical Devices, June 4-5, 2009
- Introduction to Medical Device Research and Making the Risk Determination, June 17, 2009
- FDA Workshop: Methodologies for Post-Approval Studies of Medical Devices, September 9-10, 2009
- Center for Devices and Radiological Health Forum for International Medical Device Regulatory Authorities, September 14-16, 2009
- 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009
- FDA Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes, October 29-30, 2009
- FDA-IDSA Public Workshop: Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections, November 12-13, 2009
|
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| |
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|
Rules |
Medical Devices; Immunology
and Microbiology Devices:
Classification of Respiratory Viral Panel Multiplex Nucleic Acid
Assay
5213652138 [E924432]
[TEXT] [PDF]
|
|
Notices |
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
ENTEREG; U.S. Patent Nos. 5,250,542 and 5,434,171
5224152242 [E924457]
[TEXT] [PDF]
Draft Guidance for Industry
and Food and Drug
Administration Staff:
Mammography Quality Standards Act Final Regulations,
etc.
5224252243 [E924435]
[TEXT] [PDF]
Guidances for Industry and
Food and Drug Administration
Staff:
Class II Special Controls Guidance Documents;
Respiratory Viral Panel
Multiplex Nucleic Acid
Assay, etc.
5224452245 [E924431]
[TEXT] [PDF] |
|
|
|
|
|
Rules
- NONE |
|
|
|
Notices |
Guidance for Industry and
Food and Drug Administration
Staff; Availability:
Implementation of Medical Device Establishment
Registration, etc.
5186451865 [E924349]
[TEXT] [PDF] |
|
|
|
|
|
Rules
- NONE |
|
|
|
Notices |
Draft Guidance for Industry:
Ingredients Declared as Evaporated Cane Juice;
Availability
51610 [E924132]
[TEXT] [PDF]
Regulation of Tobacco
Products; Extension of
Comment Period; Correction
51614 [E924214]
[TEXT] [PDF] |
|
|
|
|
|
Rules
- NONE |
|
|
|
Notices |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
5128751288 [E924047]
[TEXT] [PDF]
5128551287 [E924048]
[TEXT] [PDF]
Medical Devices:
Availability of Safety and Effectiveness Summaries for
Premarket Approval
Applications
5128851289 [E923962]
[TEXT] [PDF]
Meetings:
Cardiovascular and Renal Drugs Advisory Committee
51292 [E924015]
[TEXT] [PDF]
Cardiovascular and Renal Drugs Advisory Committee and
the Drug Safety and Risk
Management Advisory
Committee
5129251293 [E924014]
[TEXT] [PDF]
Orthopaedic and Rehabilitation Devices Panel of the
Medical Devices Advisory
Committee
5129151292 [E924016]
[TEXT] [PDF]
Pediatric Advisory Committee
5128951290 [E924013]
[TEXT] [PDF] |
|
|
|
|
|
Proposed Rules |
Current Good Manufacturing
Practice Requirements for
Combination Products;
Correction
51099 [E923899]
[TEXT] [PDF]
|
|
Notices |
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
EMEND FOR INJECTION
5115951160 [E923900]
[TEXT] [PDF]
Draft Guidance for Industry
and FDA Staff:
Scope of the Prohibition Against Marketing a Tobacco
Product in Combination With
Another Article or Product,
etc.
5116051161 [E923866]
[TEXT] [PDF]
Draft Guidance for Industry:
Helicobacter pyloriAssociated Duodenal Ulcer Disease
in Adults; Developing Drugs
for Treatment; Availability
51161 [E923875]
[TEXT] [PDF]
Meetings:
Food and Drug Administration Transparency Task Force
5116151163 [E923916]
[TEXT] [PDF]
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