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October 23,
2009
October 22,
2009
October 21,
2009
October 20,
2009
October 19,
2009
|
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October 23,
2009
-
-
Atacand
(candesartan
cilexetil)
Tablets,
AstraZeneca,
Efficacy
Supplement
with
Clinical
Data
to
Support
-
Actoplus
Met
(pioglitazone
hydrochloride
and
metformin
hydrochloride)
Tablets,
Takeda
Global
Research
&
Development
Center,
Inc.,
Supplement
-
Chenodiol
Tablets,
Nexgen
Pharma,
Inc.,
Approval
-
Risperidone
Tablets,
Synthon
Pharmaceuticals,
Inc.,
Approval
October 21,
2009
-
-
Albenza
(albendazole)
Tablets,
GlaxoSmithKline,
Labeling
Revision
-
Atomoxetine
Hydrochloride
Capsules,
Zydus
Pharmaceuticals
USA,
Inc.,
Tentative
Approval
-
Azulfidine
(sulfasalazine)
Tablets,
Pharmacia
&
Upjohn
Co.,
Labeling
Revision
-
Azulfidine
EN-Tabs
(sulfasalazine)
Tablets,
Pharmacia
&
Upjohn
Co.,
Labeling
Revision
-
Chantix
(varenicline
tartrate)
Tablets,
Pfizer,
Inc.,
Labeling
Revision
-
Chlorothiazide
Sodium
Injection,
APP
Pharmaceuticals,
LLC,
Approval
-
Colcrys
(colchicine)
Tablets,
Mutual
Pharmaceutical
Co.,
Inc.,
Approval
-
Hepsera
(adefovir
dipivoxil)
Tablets,
Gilead
Sciences,
Inc.,
Labeling
Revision
-
Micardis
(telmisartan)
Tablets,
Boehringer
Ingelheim
Pharmaceuticals,
Inc.,
New
or
Modified
Indication
-
Perindopril
Erbumine
Tablets,
Roxane
Laboratories,
Inc.,
Tentative
Approval
October 20,
2009
-
-
Locoid
Lipocream
(hydrocortisone
butyrate)
Topical
Cream,
Triax
Pharmaceuticals,
Efficacy
Supplement
with
Clinical
Data
to
Support
-
Votrient
(pazopanib
hydrochloride)
Tablets,
GlaxoSmithKline,
Approval
October 19,
2009
-
-
Banzel
(rufinamide)
Tablets,
Eisai
Medical
Research,
Inc.,
Labeling
Revision
-
Crestor
(rosuvastatin
calcium)
Tablets,
IPR
Pharmaceuticals,
Inc.,
Efficacy
Supplement
with
Clinical
Data
to
Support
-
Crixivan
(indinavir
sulfate)
Capsules,
Merck
&
Co.,
Inc.,
Labeling
Revision
-
Depakote
(divalproex
sodium)
Extended-Release
Tablets,
Abbott
Laboratories,
Efficacy
Supplement
with
Clinical
Data
to
Support
-
Fentanyl
Transdermal
System,
Hisamitsu
Pharmaceutical
Co.,
Inc.,
Approval
-
Risperidone
Tablets,
Sandoz,
Inc.,
Approval
|
|
|
-
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
|
|
|
|
|
|
|
|
- Common Ingredients in U.S. Licensed Vaccines
Posted: 10/23/2009
- Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments
Updated: 10/23/2009
- Influenza Virus Vaccine for the 2009-2010 Season
Lot Release information, Updated: 10/21/2009
- Fluarix
Influenza Virus Vaccine, Posted: 10/21/2009
- Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, October 2009 (PDF - 737KB)
Posted: 10/21/2009
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release information, Updated: 10/21/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Regulatory Counsel (ADP/OD), Posted: 10/21/2009
- FDA-NCI Workshop on Therapeutic Cancer Vaccines
Meeting location change, Updated: 10/21/2009
- Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 91KB)
Posted: 10/20/2009
- Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 325KB)
Posted: 10/20/2009
- North American Coral Snake Antivenin (Micrurus fulvius) (Equine) Lot 4030026 - Extended Dating Period to October 31, 2010
Extended dating period, Updated: 10/20/2009
- Complete List of Licensed Products and Establishments
Updated: 10/19/2009
- MyCells Autologous Platelet Preparation Kit
Substantially Equivalent 510(k) Device Information - BK080057, Posted 10/19/2009
- SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities
Updated: 10/19/2009
|
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|
- About CBER
- CBER Vision & Mission
Biologics Research, Regulatory Information, Safety & Availability, Guidances, Development & Approval, Enforcement & Compliance
- News & Events (Biologics)
What's New, Meetings & Workshops
- CBER Reports
CBER Annual Report, Performance, FDAMA, PDUFA, FDAAA, PREA
- Biologics Regulated Products
Allergenics, Blood & Blood Products, Cellular & Gene Therapy Products, Tissue & Tissue Products, Vaccines, Xenotransplantation
- Contacts in the Center for Biologics Evaluation & Research (CBER)
Consumer questions, manufacturer's assistance, media inquiries, technical questions, requesting speakers, establishment registration...
- Jobs at the Center for Biologics Evaluation and Research (CBER)
- Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates
- Biologics Electronic Reading Room (eFOI)
Documents frequently requested through the Freedom of Information Act.
|
|
|
|
October 22, 2009
October 21, 2009
October 20, 2009
October 19, 2009
|
|
|
|
|
|
|
|
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|
RULES |
New Animal Drug Applications
5474954751 [E925517]
[TEXT] [PDF] |
|
|
|
Proposed Rules |
New Animal Drug Applications
5477154773 [E925518]
[TEXT] [PDF]
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
5482754829 [E925537]
[TEXT] [PDF]
5482654827 [E925538]
[TEXT] [PDF]
5482654827 [E925538]
[TEXT] [PDF]
|
|
|
|
|
|
RULES
- NONE |
|
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
5457054571 [E925395]
[TEXT] [PDF]
Meetings:
Radiological Devices Panel of the Medical Devices
Advisory Committee
54583 [E925406]
[TEXT] [PDF]
Request for Notification
From Industry Organizations
Interested in Participating
in Selection Process:
Nonvoting Industry Representatives on Public Advisory
Committees, et al.
5458954590 [E925407]
[TEXT] [PDF]
|
|
|
|
|
|
RULES |
Medical Devices:
Clinical Chemistry and Clinical Toxicology Devices;
Classification of the
Cardiac Allograft Gene
Expression Profiling Test
Systems
5388353885 [E925315]
[TEXT] [PDF]
|
|
NOTICES |
Debarment Order:
Wallace E. Gonsalves, Jr., MD
5405154052 [E925322]
[TEXT] [PDF]
Draft Guidance for Industry:
Registration and Product Listing for Owners and
Operators of Domestic
Tobacco Product
Establishments
5405254053 [E925235]
[TEXT] [PDF]
Draft Guidances for Industry
and Food and Drug
Administration Staff:
Computer-Assisted Detection Devices Applied to
Radiology Images and
Radiology Device Data
Premarket Notification
Submissions, etc.
5405354055 [E925233]
[TEXT] [PDF]
Guidance for Industry and
Food and Drug Administration
Staff:
Class II Special Controls Guidance Document; Cardiac
Allograft Gene Expression
Profiling Test Systems
5405554056 [E925313]
[TEXT] [PDF] |
|
|
|
|
|
RULES
- NONE |
|
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
5374653749 [E925100]
[TEXT] [PDF]
5374353746 [E925102]
[TEXT] [PDF]
5375053751 [E925177]
[TEXT] [PDF]
5374953750 [E925178]
[TEXT] [PDF]
Draft Guidance for Industry
and Food and Drug
Administration Staff:
Investigational New Drug Applications for Minimally
Manipulated, Unrelated
Allogeneic
Placental/Umbilical Cord
Blood, etc.
5375153752 [E925136]
[TEXT] [PDF]
Guidance for Industry:
Minimally Manipulated, Unrelated Allogeneic
Placental/Umbilical Cord
Blood Intended for
Hematopoietic Reconstitution
for Specified Indications
5375353754 [E925135]
[TEXT] [PDF]
Web Location of 2010
Proposed Guidance
Development
5375453755 [E925179]
[TEXT] [PDF]
|
|
|
|
RULES - NONE |
|
|
|
NOTICES |
Guidance for Industry and
Review Staff on Labeling for
Human Prescription Drug and
Biological Products, etc.:
Availability
5350753508 [E924991]
[TEXT] [PDF]
Meetings:
Risk Evaluation and Mitigation Strategies for Certain
Opioid Drugs
5350953510 [E925022]
[TEXT] [PDF]
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