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January 8, 2010
January 7, 2010
January 4, 2010
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January 8, 2009
- Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
- Boniva (ibandronate sodium) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
- Carisoprodol, Aspirin, and Codeine Phosphate Tablets, Concord Laboratories, Inc., Approval
- Carisoprodol and Aspirin Tablets, Concord Laboratories, Inc., Approval
- Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Ibandronate Sodium Tablets, Orchid Healthcare, Tentative Approval
- Ibandronate Sodium Tablets, Cobalt Laboratories, Inc., Tentative Approval
- Lamisil AT (terbinafine) Gel, Novartis Consumer Health, Labeling Revision
- Memantine Hydrochloride Tablets, Orchid Healthcare, Tentative Approval
- Memantine Hydrochloride Tablets, Amneal Pharmaceuticals, Tentative Approval
- Topiramate Tablets, Upsher-Smith Laboratories, Inc., Approval
- Urocit-K (potassium citrate) Extended-Release Tablets, Mission Pharmacal, Manufacturing Change or Addition
January 6, 2009
- Actonel (risedronate sodium) Tablets, Procter & Gamble Pharmaceuticals, Inc., Labeling Revision
- Catapres (clonidine hydrochloride) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
- Commit (nicotine polacrilex) Lozenge, GlaxoSmithKline Consumer Healthcare, Labeling Revision
- Detrol LA (tolterodine tartrate) Extended Release Capsules, Pfizer Global Research and Development, Labeling Revision
- Didronel (etidronate disodium) Tablets, Procter & Gamble Pharmaceuticals, Inc., Labeling Revision
- Ibandronate Sodium Tablets, Cobalt Laboratories Inc., Tentative Approval
- Janumet (metformin hydrochloride and sitagliptin phosphate) Tablets, Merck & Co., Inc., Labeling Revision
- Lyrica (pregabalin) Oral Solution, Pfizer, Inc., Approval
- Lyrica (pregabalin) Capsules, Pfizer, Inc., Labeling Revision
- Prempro (estrogens, conjugated and medroxyprogesterone acetate) Tablets, Wyeth Pharmaceuticals Inc., Labeling Revision
- Solage (mequinol and tretinoin) Topical Solution, Stiefel Laboratories, Inc., Labeling Revision
- Xolegel (ketoconazole) Gel, Stiefel Laboratories, Inc., Labeling Revision
- Ultravist (iopromide) Injection, Bayer HealthCare Pharmaceuticals Inc., Efficacy Supp. w/Clinical Data
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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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- InterSol Solution/Platelet Additive Solution 3
Approval History, Letters, Reviews, and Related Documents, Updated: 1/8/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary Scientist (Microbiologist), OVRR/DVRPA, Updated: 1/8/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary Scientist (Chemist), OVRR/DVRPA, Updated: 1/8/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary Scientist (Biologist), OVRR/DVRPA, Updated: 1/8/2010
- Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 171KB)
Updated: 1/8/2010
- Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 36KB)
Updated: 1/8/2010
- Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 843KB)
Updated: 1/8/2010
- ROTARIX
12/30/2009 Approval Letter, Package Insert and Patient Information updated.
Posted 1/7/2010
- Recall: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
MedImmune LLC, Posted: 1/7/2010
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot release information, Updated: 1/6/2010
- Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 1/6/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Contract Specialist (Direct Hire), Various centers, Posted: 1/6/2010
- Biologics Sentinel Initiative Projects
Posted: 1/5/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Biologist, LMDCI/DBPAP/OVRR, Posted: 1/5/2010
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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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RULES |
Certain Other Dosage Form
New Animal Drugs:
Sevoflurane
1021 [201047]
[TEXT] [PDF]
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NOTICES |
Draft Guidance for Industry:
Planning for the Effects of High Absenteeism to Ensure
Availability of Medically
Necessary Drug Products;
Availability
10601062 [201087]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES
- NONE |
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RULES
- NONE |
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NOTICES |
Guidance for Industry:
New Contrast Imaging Indication Considerations for
Devices and Approved Drug
and Biological Products;
Availability
875876 [E931307]
[TEXT] [PDF]
Meetings:
Anesthetic and Life Support Drugs Advisory Committee;
Cancellation
876 [E931306]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
379382 [E931199]
[TEXT] [PDF]
373379 [E931200]
[TEXT] [PDF]
Canned Pacific Salmon
Deviating From Identity
Standard:
Extension of Temporary Permit for Market Testing
383384 [E931196]
[TEXT] [PDF]
Event Problem Codes Web
Site; Center for Devices and
Radiological Health;
Availability
384385 [E931197]
[TEXT] [PDF]
Memorandum of Understanding:
United States Department of Health and Human Services,
Food and Drug
Administration, Center for
Drug Evaluation and Research
and Northeastern University
386390 [E931195]
[TEXT] [PDF]
Public Workshop:
Medical Device Quality System Regulation Educational
Forum on Risk Management
Through the Product Life
Cycle
391 [E931198]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES
- NONE |
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