August 7, 2009
August 6, 2009
August 5, 2009
August 4, 2009
August 3, 2009
Drug
Approvals
August 7, 2009
-
-
Carisoprodol
Tablets,
Aurobindo
Pharma,
Ltd.,
Approval
-
Lamivudine
Tablets,
Strides
Arcolab,
Ltd.,
Tentative
Approval
-
Onglyza
(saxagliptin)
Tablets,
Bristol-Myers
Squibb Co.,
Approval
August 5, 2009
-
-
Divalproex
Sodium
Extended-Release
Tablets,
Zydus
Pharmaceuticals
USA Inc.,
Supplement
-
Divalproex
Sodium
Extended-Release
Tablets,
IMPAX
Laboratories,
Inc.,
Supplement
-
Divalproex
Sodium
Extended-Release
Tablets,
Anchen
Pharmaceuticals,
Inc.,
Supplement
-
Divalproex
Sodium
Extended-Release
Tablets,
Wockhardt
Ltd.,
Supplement
-
Idarubicin
Hydrochloride
Injection,
APP
Pharmaceuticals,
LLC,
Approval
August 4, 2009
-
-
Azelastine
Hydrochloride
Ophthalmic
Solution,
Apotex Inc.,
Approval
-
Betamethasone
Acetate and
Betamethasone
Sodium
Phosphate
Injection,
PharmaForce,
Inc.,
Approval
-
Divalproex
Sodium
Extended-Release
Tablets,
Teva
Pharmaceuticals,
Approval
-
Efavirenz
Capsules,
Cipla Ltd.,
Tentative
Approval
-
Invega
(paliperidone)
Extended
Release
Tablets,
Johnson &
Johnson
Pharmaceutical
Research &
Development,
L.L.C.,
Labeling
Revisions
-
Metoprolol
Succinate
Extended-Release
Tablets,
Watson
Laboratories,
Inc.,
Approval
-
Metoprolol
Succinate
Extended-Release
Tablets,
Watson
Laboratories,
Inc.,
Approval
-
Oxaliplatin
Injection,
Sandoz Inc.,
Tentative
Approval
Meetings
-
2009
PDA/FDA
Joint
Regulatory
Conference,
September
14-18,
2009,
Renaissance
Hotel,
999
9th
Street
NW,
Washington,
D.C.
Meeting
Information
and
registration
-
Providing
Effective
Information
to
Consumers
about
Prescription
Drug
Risks
and
Benefits;
Public
Workshop,
September
24-25,
2009,
Gaithersburg,
MD
20877.
Meeting
Information
-
CDER
Forum
for
International
Drug
Regulatory
Authorities,
October
5-9,
2009,
Silver
Spring,
MD.
CDER
Drug Links
|
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Biologist (OCTGT), Posted: 8/7/2009
- 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
July 23, 2009 Meeting Transcript, Updated: 8/7/2009
- Bone Marrow Collection/Transfusion Kit
BK090031 - Substantially Equivalent 510(k) Device Information, Posted: 8/7/2009
- Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine, Posted: 8/6/2009
- Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 8/5/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Analyst (OM), Posted: 8/5/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Health Science Administrator (OM), Posted: 8/5/2009
- FDA-NCI Workshop on Therapeutic Cancer Vaccines
Posted: 8/5/2009
August 03, 2009 - Tanimura & Antle Expands Possible Distribution Area of Voluntary Romaine Recall
- 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.
|
- August 07, 2009 - FDA: Tuna Salad Sandwiches, Other Products Seized at Louisiana Company
- August 07, 2009 - FDA Enhances Speed and Transparency of Actions Taken Against Misconduct in Drug and Device Development
- August 06, 2009 - FDA Commissioner Sets Out Vision on Enforcement to Support Public Health
- August 06, 2009 - FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination
- August 04, 2009 - FDA: Cancer Warnings Required for TNF Blockers
- August 03, 2009 - FDA Approves New Cholesterol-Lowering Drug
- August 03, 2009 - FDA Gives Update on Botulinum Toxin Safety Warnings; Established Names of Drugs Changed
- August 03, 2009 - FDA, European Medicines Agency Launch Good Clinical Practices Initiative
|
|
This
Week
Rule Changes:
21 CFR Parts
872
-
510 -
524 |
|
Friday,
August
7, 2009 |
NOTICES
Guidance for Industry on
Pharmaceutical Components at
Risk for Melamine
Contamination; Availability
3970439705 [E918952]
[TEXT] [PDF]
|
|
Thursday,
August
6, 2009 |
|
NONE |
|
Wednesday,
August 5, 2009 |
|
NONE
|
|
Tuesday,
August 4, 2009 |
RULES
Dental Devices:
Classification of Dental
Amalgam, Reclassification of
Dental Mercury, Designation
of Special Controls for
Dental Amalgam, Mercury, and
Amalgam Alloy
3868638714 [E918447]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
38634 [E918532]
[TEXT] [PDF]
Authorization of Emergency
Use of Certain In Vitro
Diagnostic Devices;
Availability
3863638644 [E918569]
[TEXT] [PDF]
Authorization of Emergency
Use of Certain Personal
Respiratory Protection
Devices; Availability
3864438648 [E918570]
[TEXT] [PDF]
Authorizations of Emergency
Use of Certain Antiviral
Drugs:
Zanamivir and Oseltamivir
Phosphate
3864838654 [E918568]
[TEXT] [PDF]
Cooperative Agreement
Between the Food and Drug
Administration and the
Dauphin Island Sea Lab
3865538656 [E918533]
[TEXT] [PDF]
Debarment Order:
Kim C. Hendrick
3865638657 [E918621]
[TEXT] [PDF]
Paul H. Kornak
3865738658 [E918619]
[TEXT] [PDF]
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
EOVIST
3866038661 [E918527]
[TEXT] [PDF]
RECOTHROM
3865838659 [E918528]
[TEXT] [PDF]
XIENCE V EECSS
3865938660 [E918530]
[TEXT] [PDF]
Guidance for Industry and
Food and Drug Administration
Staff:
Class II Special Controls
Guidance Document: Dental
Amalgam, Mercury, and
Amalgam Alloy
3866138662 [E918445]
[TEXT] [PDF]
|
|
Monday,
August 3, 2009 |
|
RULES
New Animal Drugs:
Nitrofurazone Ointment
3834138342 [E918337]
[TEXT] [PDF]
NOTICES
Animal Drug User Fee Rates
and Payment Procedures
(Fiscal Year 2010)
3842938434 [E918459]
[TEXT] [PDF]
Animal Generic Drug User Fee
Rates and Payment Procedures
(Fiscal Year 2010)
3843438437 [E918458]
[TEXT] [PDF]
Draft Guidance for Industry:
Guide to Minimize Microbial
Food Safety Hazards of Leafy
Greens; Availability
3843938440 [E918451]
[TEXT] [PDF]
Guide to Minimize Microbial
Food Safety Hazards of
Melons; Availability
3843738438 [E918452]
[TEXT] [PDF]
Guide to Minimize Microbial
Food Safety Hazards of
Tomatoes; Availability
3843838439 [E918453]
[TEXT] [PDF]
Medical Device User Fee
Rates (Fiscal Year 2010)
3844438449 [E918456]
[TEXT] [PDF]
Prescription Drug User Fee
Rates (Fiscal Year 2010)
3845138456 [E918457]
[TEXT] [PDF]
Seafood Hazard Analysis and
Critical Control Points
Alliance for Education and
Training
3846238463 [E918416]
[TEXT] [PDF]
|
|
|
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