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December 24,
2009
December 23,
2009
December 22,
2009
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December 24, 2009
- Amlodipine besylate/Benazepril hydrochloride Capsules, Novartis Pharmaceuticals Corporation, Manufacturing Change or Addition
- Ampicillin and Sulbactam Injection, ACS Dobfar, Approval
- Carvedilol Tablets, Wockhardt Limited, Approval
- Ciprofloxacin Injection, Hikma Farmaceutica, Approval
- Epirubicin Hydrochloride Injection, EBEWE Pharma, Approval
- Etomidate Injection, PharmaForce, Inc., Approval
- Flomax (tamsulosin hydrochloride) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., Efficacy Supp. w/Clinical Data
- Fuzeon (enfuvirtide) Injection, Hoffmann-La Roche, Inc., Labeling Revision
- Gemcitabine Injection, Watson Laboratories, Inc., Tentative Approval
- Mycophenolate Mofetil Capsules, Endo Pharmaceuticals, Inc., Approval
- Neoprofen (ibuprofen lysine) Injection, Lundbeck Inc., Labeling Revision
- Pramipexole Dihydrochloride Tablets, Glenmark Generics Limited, Tentative Approval
- Risperidone Orally Disintegrating Tablets, Sandoz Inc., Approval
- Topamax (topiramate) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision and Efficacy Supp.
- Topamax (topiramate) Sprinkle Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision and Efficacy Supp.
December 22, 2009
- Bicillin C-R (penicillin G benzathine, pencillin G procraine) Injection, King Pharmaceuticals, Labeling Revision
- Bicillin L-A (penicillin G benzathine) Injection, King Pharmaceuticals, Labeling Revision
- Cromolyn Sodium Oral Concentrate, Genera Pharmaceuticals, Approval
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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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- Jobs at the Center for Biologics Evaluation and Research (CBER)
Biologist, OBRR/DETTD/LMV, Posted: 12/17/2009
- 2009 Meeting Materials of the Blood Products Advisory Committee
November 16-17, 2009 Meeting Transcripts, Posted: 12/16/2009
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot release information, Updated: 12/16/2009
- Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 12/16/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Biostatistics Fellowship, OBE, Posted: 12/15/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Chemist, OVRR/DBPAP/LRSP, Posted: 12/15/2009
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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
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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
- NONE |
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NOTICES
- NONE |
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RULES |
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NOTICES |
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RULES
- NONE |
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NOTICES |
International Conference on
Harmonisation:
Guidance on Q4B Evaluation
and Recommendation of
Pharmacopoeial Texts for Use
in the International
Conference on Harmonisation
Regions
6827068271 [E930441]
[TEXT] [PDF]
Meetings:
Gastrointestinal Drugs Advisory Committee
68272 [E930442]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
International Conference on
Harmonisation:
Guidance on Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use
in the International
Conference on Harmonisation
Regions
6806868069 [E930326]
[TEXT] [PDF]
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RULES |
Implantation or Injectable
Dosage Form New Animal
Drugs:
Polysulfated Glycosaminoglycan
6781567816 [E930222]
[TEXT] [PDF]
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NOTICES |
Guidance for Industry on the
Timeframe for Submission of
Tobacco Health Documents;
Availability
6787767878 [E930297]
[TEXT] [PDF] |
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