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January 15, 2010
January 14, 2010
January 13, 2010
January 12, 2010
January 11, 2010
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January 14, 2009
- Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics, Inc., Labeling Revision
- Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, Schwarz Pharma, Labeling Revision
- Viramune (nevirapine) Oral Suspension, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
- Viramune (nevirapine) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
January 13, 2009
- Ibutilide Fumarate Injection, GeneraMedix Inc., Approval
- Ibutilide Fumarate Injection, PharmaForce, Inc., Approval
- Ibutilide Fumarate Injection, Bioniche Pharma, Approval
- Levofloxacin Tablets, Wockhardt Ltd., Tentative Approval
- Vasovist (gadofosveset trisodium) Injection, Lantheus Medical Imaging, Labeling Revision
January 12, 2009
- Actemra (tocilizumab) Injection, Genentech, Inc., Approval
- Clarinex-D 12 Hour (desloratadine and pseudoephedrine sulfate) Extended Release Tablets, Schering-Plough, Labeling Revision
- Clarinex-D 24 Hour (desloratadine and pseudoephedrine sulfate) Extended Release Tablets, Schering-Plough, Labeling Revision
- Desonate (desonide) Gel, Intendis, Inc., Labeling Revision
- Famvir (famciclovir) Tablets, Novartis Pharmaceuticals Corp., Efficacy Supplement with Clinical Data to Support
- Innopran XL (propranolol hydrochloride) Extended Release Capsules, GlaxoSmithKline, Labeling Revision
- Januvia (sitagliptin phosphate) Tablets, Merck & Co., Inc., Labeling Revision
- Methotrexate Sodium Preservative Free (methotrexate sodium) Injection, Pharmachemie B.V., Approval
- Remodulin (treprostinil sodium) I.V. Injection, United Therapeutics Corp., Labeling Revision
- Solodyn (minocycline hydrochloride) Extended Release Tablets, Medicis Pharmaceutical Corp., Labeling Revision
- Vancocin Hydrochloride Capsules, ViroPharma Inc., Labeling Revision
- Velcade (bortezomib) Intravenous Injection, Millennium Pharmaceuticals, Efficacy Supplement with Clinical Data to Support
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- FDA Orphan Drugs Workshops, February 25-26, 2010, Claremont, CA; August 3-4, 2010, Minneapolis, MN. Meeting Brochure (PDF - 91 KB)
- Indexing Labeling for Human Drug and Biological Products using Structured Product Labeling (SPL). February 2010.
- FDA/DIA 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, February 2-4, 2010, Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD. Meeting Information and registration
- DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Meeting information and registration
- 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration
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Guidance
Approved Drugs
Approval Process
Electronic Submissions
Firm Registration Status
Good Manufacturing Practice
Regulations
National Drug Code Directory
MedWatch: Adverse Event
Reporting
Download Forms
Generic Drugs
Small Business
En
Espaρol
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- Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating
Posted: 1/15/2010
- 2010 Advisory Committee Tentative Meetings
Meeting Cancelled: April 30, 2010, Allergenic Products Advisory Committee, Posted: 1/15/2010
- February 22, 2010: Meeting of the Vaccines and Related Biological Products Advisory Committee
Meeting Announcement, Posted: January 15, 2010
- Influenza Virus Vaccine Actions
Updated: 1/14/2010
- Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Questions and Answers
Posted: 1/13/2010
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot release information, Updated: 1/13/2010
- Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 1/13/2010
- Complete List of Licensed Products and Establishments
Updated: 1/12/2010
- Fast Track Designation Request Performance
Updated: 1/12/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Chemist, OVRR/DPQ/PQLS, Posted: 1/12/2010
- Pentacel
12/22/2009 Approval Letter, updated Package Insert to revise labeling to comply with Physician's Labeling Rule format, Updated: 1/11/2010
- Clinical Investigator Status (Biologics)
Clinical Investigator Inspection List, Updated: 1/11/2010
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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.
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January 15, 2010
January 11, 2010
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-
The A to Z of Off Label
Issues, February 9, 2010
-
Public Meeting:
Incorporation of New
Science Into Regulatory
Decision-making Within
the Center for Devices
and Radiological Health
- February 9, 2010
-
510(k) Submissions - The
Course for Beginning RA
Professionals for
Preparing a 510(k),
February 22-23, 2010
-
Investigational Device
Exemption (IDE)
Submission Workshop,
February 24, 2010
-
PMA Submissions
Workshop, February
25-26, 2010
-
Forum for International
Medical Device
Regulatory Authorities,
May 3-6, 2010
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Guidance Documents (Medical Devices)
How to Market Your Device
Postmarket Requirements (Devices)
Importing and Exporting Devices
International Information (Devices)
Device Classification
Bioresearch Monitoring
FDA eSubmitter
CDRH Learn
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RULES
- NONE |
|
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NOTICES |
Meetings:
Clinical Accuracy Requirements for Point of Care Blood
Glucose Meters; Request for
Comments
25492550 [2010742]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
Draft Guidance for Industry:
Tobacco Health Document Submission; Availability;
Correction
21452146 [2010576]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
Draft Guidance for
Institutional Review Boards,
Clinical Investigators, and
Sponsors:
IRB Continuing Review After Clinical Investigation
Approval; Availability
17901791 [2010426]
[TEXT] [PDF]
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RULES - NONE |
|
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NOTICES |
Denial of Hearing; Final
Debarment Order:
Jason Vale
16231625 [2010289]
[TEXT] [PDF]
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RULES |
Implantation or Injectable
Dosage Form New Animal
Drugs:
Florfenicol and Flunixin
12741275 [2010209]
[TEXT] [PDF]
Hyaluronate Sodium
1274 [2010207]
[TEXT] [PDF]
New Animal Drugs:
Ractopamine
12751276 [2010208]
[TEXT] [PDF]
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NOTICES |
Meetings:
Cardiovascular and Renal Drugs Advisory Committee
13951396 [2010173]
[TEXT] [PDF]
General and Plastic Surgery Devices Panel of the
Medical Devices Advisory
Committee; Amendment
1395 [2010172]
[TEXT] [PDF]
General Hospital and Personal Use Devices Panel of the
Medical Devices Advisory
Committee
13961397 [2010174]
[TEXT] [PDF]
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