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January 29, 2010
January 28, 2010
January 27, 2010
January 26, 2010
January 25, 2010
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January 28, 2010
- Demadex (torsemide) Tablets, Meda Pharmaceuticals, Labeling Revision
- Oxcarbazepine Tablets, Cadista Pharmaceuticals, Inc., Approval
- Perindopril Erbumine Tablets, Lupin Limited, Approval
- Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Symbyax (olanzapine and fluoxetine hydrochloride) Capsules, Eli Lilly and Company, Labeling Revision
- Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Company, Labeling Revision
- Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Labeling Revision
- Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Company, Labeling Revision
January 27, 2010
- Morphine Sulfate Oral Solution, Roxane Laboratories, Inc., Efficacy
- Videx (didanosine) Oral Solution, Bristol-Myers Squibb Co., Supplement
- Videx EC (didanosine) Delayed-Release Capsules, Bristol-Myers Squibb Co. Supplement
- Zoledronic Acid Injection, Hospira, Inc., Tentative Approval
January 26, 2010
- Victoza (liraglutide) Subcutaneous Solution, Novo Nordisk, Inc., Approval
January 25, 2010
- AMPYRA (dalfampridine) Extended-Release Tablets, Acorda Therapeutics, Inc., Approval
- Bumex (bumetanide) Tablets, Validus Pharmaceuticals, Labeling Revision
- Coumadin (warfarin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Crestor (rosuvastatin calcium) Tablets, IPR Pharmaceuticals, Inc., Labeling Revision
- Ethrane (enflurane) Inhalation Liquid, Baxter Healthcare Corp., Labeling Revision
- Lusedra (fospropofol disodium) I.V. Solution, Eisai Inc., Labeling Revision
- Mephyton (Phytonadione) Tablets, Aton Pharma, Inc., Labeling Revision
- Milrinone Lactate in Plastic Containers Injection, Hikma Farmaceutica, Approval
- Qualaquin (quinine sulfate) Capsules, AR Holding Company, Inc., Labeling Revision
- Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Labeling Revision
- Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, Glenmark Generics, Tentative Approval
- Ultane (sevoflurane) Liquid Inhalation, Abbott Laboratories, Labeling Revision
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- FDA Technical Briefing on Its FY 2011 Budget Request, Monday, February 1, 3:30 p.m. EST.
- 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
Español
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- Influenza Virus Vaccine Actions
Updated: 1/29/2010
- 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
December 15, 2009 Meeting Transcript, Posted: 1/29/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Support Specialist, OVRR/DVRPA, Updated: 1/29/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Pharmacist /Lead /Supv Pharmacist, Direct Hire, Posted: 1/29/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Medical Officer/Lead /Supv Med Officer, Direct Hire, Posted: 1/29/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Veterinary Medical Officer/Lead/Supervisory, Direct Hire, Posted: 1/29/2010
- Cord Blood Licensure: A Workshop
Posted: 1/27/2010
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Updated: 1/27/2010
- Flebogamma DIF 5%
Updated Package Insert. Updated: 1/26/2010
- WinRho SDF Liquid
Updated Package Insert, Patient Information, "Dear Healthcare Provider" Letter with Drug Warning Information. Updated: 1/26/2010
- Blood Establishment Computer Software: Understanding What to Include in a 510(k) Submission; Public Workshop
Transcripts Posted, Updated: 1/26/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Support Specialist, OVRR/DVRPA, Posted: 1/26/2010
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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 29, 2010
January 28, 2010
January 27, 2010
January 26, 2010
January 25, 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
-
FDA/CDRH Public Meeting:
Blood Glucose Meters -
March 16-17, 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 |
Implantation or Injectable
Dosage Form New Animal
Drugs:
Ceftiofur Crystalline Free Acid
4692 [2010–1790]
[TEXT] [PDF]
Ophthalmic and Topical
Dosage Form New Animal
Drugs:
Miconazole, Polymixin B, and Prednisolone Suspension
4692–4693 [2010–1794]
[TEXT] [PDF]
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NOTICES
- NONE |
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RULES
- NONE |
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NOTICES |
Meetings:
Veterinary Medicine Advisory Committee
4576 [2010–1626]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
Draft Guidance:
Industry on Assessment of Abuse Potential of Drugs;
Availabilit
4400–4401 [2010–1516]
[TEXT] [PDF]
Guidance for Industry:
Use of Mechanical Calibration of Dissolution Apparatus
1 and 2Current Good
Manufacturing Practice;
Availability
4401–4402 [2010–1517]
[TEXT] [PDF]
Meetings:
Neurological Devices Panel of the Medical Devices
Advisory Committee
4407–4408 [2010–1519]
[TEXT] [PDF]
Science Board to the Food and Drug Administration
4407 [2010–1520]
[TEXT] [PDF]
Strengthening the Center for Devices and Radiological
Health's 510(k) Review
Process
4402–4406 [2010–1620]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
4079–4080 [2010–1435]
[TEXT] [PDF]
4077–4079 [2010–1436]
[TEXT] [PDF]
4087 [2010–1437]
[TEXT] [PDF]
4086–4087 [2010–1438]
[TEXT] [PDF]
4081–4086 [2010–1439]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES
- NONE |
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