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News |
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October 2, 2009
October 1, 2009
September 30,
2009
September 29,
2009
September 28,
2009
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Drug Approvals |
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October 2, 2009
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Alfuzosin
Hydrochloride
Extended-Release
Tablets, Wockhardt,
Ltd., Tentative
Approval
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Carbidopa and
Levodopa
Tablets, Mylan
Pharmaceuticals,
Inc., Approval
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Cilostazol
Tablets,
Breckenridge
Pharmaceutical,
Inc., Approval
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Cordarone (amiodarone
hydrochloride)
Tablets, Wyeth
Pharmaceuticals,
Inc., Labeling
Revision
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DepoDur
(morphine sulfate)
Liposome Injection,
Pacira
Pharmaceuticals,
Inc., Labeling
Revision
-
Invega Sustenna
(paliperidone
palmitate)
Extended-Release
Intramusculuar
Suspension,
Ortho-McNeil-Jansen
Pharmaceuticals,
Inc., Approval
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Kayexalate
(sodium polystyrene
sulfonate) Oral or
Rectal Powder,
sanofi-aventis U.S.,
LLC, Labeling
Revision
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Lithium Carbonate
Capsules, InvaGen
Pharmaceuticals,
Inc., Approval
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Maxipime (cefepime
hydrochloride)
Injection,
Bristol-Myers Squibb
Co., Labeling
Revision
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Metoprolol Tartrate
Injection, Luitpold
Pharmaceuticals,
Inc., Approval
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Ondansetron
Hydrochloride
Injection, Gland
Pharma, Ltd.,
Approval
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Oxaliplatin
Injection, Hospira
Worldwide, Inc.,
Approval
-
Renvela (sevelamer
carbonate) Oral
Suspension, Genzyme
Corp., Approval
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Stelara (ustekinumab)
Injection, Centocor
Ortho Biotech, Inc.,
Approval
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Zoledronic Acid
Injection, Bedford
Laboratories,
Tentative Approval
September 29,
2009
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Alendronate Sodium
Tablets,
AustarPharma, LLC,
Approval
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Darvon (propoxyphene
hydrochloride)
Capsules, Xanodyne
Pharmaceutical,
Inc., Labeling
Revision
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Darvon-N (propoxyphene
napsylate) Tablets,
Xanodyne
Pharmaceutical,
Inc., Labeling
Revision
-
Darvocet-N
(acetaminophen and
propoxyphene
napsylate) Tablets,
Xanodyne
Pharmaceutical,
Inc., Labeling
Revision
-
Dorzolamide
Hydrochloride and
Timolol Maleate
Ophthalmic Solution,
Teva Parenteral,
Approval
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Gemcitabine
Injection, APP
Pharmaceuticals,
LLC, Tentative
Approval
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Neoral
(cyclosporine)
Capsules, Novartis
Corp., Labeling
Revision
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Neoral
(cyclosporine) Oral
Solution, Novartis
Corporation,
Labeling Revision
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Polyethylene Glycol
3350 Oral
Solution, Novel
Laboratories, Inc.,
Tentative Approval
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Ramipril
Tablets, Zydus
Pharmaceuticals
Inc., Approval
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Tamsulosin
Hydrochloride
Capsules, Wockhardt
Ltd., Tentative
Approval
-
Timolol Maleate
Ophthalmic Solution,
Wockhardt Ltd.,
Approval
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CDER
Meetings |
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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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CDER
Links |
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News |
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CBER
Meetings |
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CBER Links |
- 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.
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News |
October
1, 2009
September 30, 2009
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| |
|
Meetings |
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FDA / NHLBI / NSF
Workshop on Computer
Methods for
Cardiovascular Devices,
June 1-2, 2009
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FDA Workshop:
Implementation of Post
Approval Studies for
Medical Devices, June
4-5, 2009
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Introduction to Medical
Device Research and
Making the Risk
Determination, June 17,
2009
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FDA Workshop:
Methodologies for
Post-Approval Studies of
Medical Devices,
September 9-10, 2009
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Center for Devices and
Radiological Health
Forum for International
Medical Device
Regulatory Authorities,
September 14-16, 2009
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2009 PDA/FDA Joint
Regulatory Conference,
September 14-18, 2009
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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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CDRH
Links |
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Weekly Rule Changes - NONE |
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Rules |
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No Rule
Changes Today |
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Notices |
Meetings:
Oncologic Drugs Advisory
Committee; Cancellation
50980 [E923764]
[TEXT] [PDF] |
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Proposed
Rules |
Postmarketing Safety
Reporting for Combination
Products
5074450758 [E923519]
[TEXT] [PDF] |
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Notices |
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
CLEVIPREX
50801 [E923650]
[TEXT] [PDF]
Draft Guidance for
Industry:
Format and Content of
Proposed Risk Evaluation and
Mitigation Strategies, REMS
Assessments, and Proposed
REMS Modifications
5080150802 [E923616]
[TEXT] [PDF]
Meetings:
National Mammography Quality
Assurance Advisory Committee
50803 [E923621]
[TEXT] [PDF]
Pilot Program to
Evaluate Proposed
Proprietary Name
Submissions:
Procedures to Register for
Participation and Submit
Data
5080650809 [E923620]
[TEXT] [PDF]
Regulation of Tobacco
Products; Extension of
Comment Period
50810 [E923607]
[TEXT] [PDF]
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Rules |
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No Rule
Changes Today |
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Notices |
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Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals |
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5021450215 [E923521]
[TEXT] [PDF] |
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Rules |
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No Rule
Changes Today |
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Notices |
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Meetings: |
Anti-Infective Drugs
Advisory Committee
49880 [E923437]
[TEXT] [PDF]
Blood Products Advisory
Committee
4988049881 [E923434]
[TEXT] [PDF] |
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Rules |
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No Rule
Changes Today |
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Notices |
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Meetings: |
Pulmonary-Allergy Drugs
Advisory Committee
4938449385 [E923270]
[TEXT] [PDF]
49384 [E923292]
[TEXT] [PDF] |
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