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February 19,
2010
February 18,
2010
February 17,
2010
February 16,
2010
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February 18, 2010
- Levofloxacin Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval
- Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision
- Ursodiol Capsules, Mylan Pharmaceuticals Inc., Approval
- Valproate Sodium Injection, Hikma Farmaceutica, Approval
February 17, 2010
February 16, 2010
- Abilify (aripiprazole) Injection, Otsuka Pharmaceutical Company, Ltd., Labeling Revision
- Amlodipine Besylate and Benazepril Hydrochloride Capsules, Lupin, Ltd., Approval
- Balanced Salt Solution, B. Braun Medical, Inc., Approval
- Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Efficacy Supplement
- Cefoxitin and Dextrose in Plastic Container Injection, B. Braun Medical, Inc., Labeling Revision
- Cetirizine Hydrochloride Syrup, Actavis Mid Atlantic, LLC, Approval
- Children's Cetirizine Hydrochloride Allergy Syrup, Aurobindo Pharma, Ltd., Approval
- Children's Cetirizine Hydrochloride Hives Relief Syrup, Aurobindo Pharma, Ltd., Approval
- Chantix (varenicline tartrate) Tablets, Pfizer, Inc., Labeling Revision
- Claritin-D (loratadine and pseudoephedrine sulfate) Extended-Release Tablets, Schering-Plough, Labeling Revision
- Claritin-D 24 Hour (loratadine and pseudoephedrine sulfate) Extended-Release Tablets, Schering-Plough, Labeling Revision
- Didrex (benzphetamine hydrochloride) Tablets, Pharmacia & Upjohn Company, Labeling Revision
- Excedrin (Migraine) (acetaminophen, aspirin and caffeine) Tablets, Novartis Consumer Health, Inc., Labeling Revision
- Genotropin (somatropin [rDNA origin]) Injection, Pharmacia & Upjohn, Labeling Revision
- Labetalol Hydrochloride Injection, Sagent Strides, LLC, Approval
- Lamictal XR (lamotrigine) Extended-Release Tablets, GlaxoSmithKline, Approval
- Lamisil (terbinafine hydrochloride) Topical Solution, Novartis Consumer Health, Inc., Labeling Revision
- Lanoxin, (digoxin) Tablets, GlaxoSmithKline, Labeling Revision
- Lanoxin (digoxin) Injection, GlaxoSmithKline, Labeling Revision
- Levetiracetam Tablets, Taro Pharmaceuticals, Approval
- Norethindrone and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval
- Norvir (ritonavir) Tablets, Abbott Laboratories, Approval
- Norvir (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Prepidil (dinoprostone) Cervical Gel, Pfizer Global Pharmaceuticals, Labeling Revision
- Savella (milnacipran hydrochloride) Tablets, Cypress Bioscience, Inc., Labeling Revision
- Xiaflex (collagenase clostridium histolyticum) Injection, Auxilium Pharmaceuticals, Inc., Approval
February 18, 2010
- Levofloxacin Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval
- Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision
- Ursodiol Capsules, Mylan Pharmaceuticals Inc., Approval
- Valproate Sodium Injection, Hikma Farmaceutica, Approval
February 17, 2010
February 16, 2010
- Abilify (aripiprazole) Injection, Otsuka Pharmaceutical Company, Ltd., Labeling Revision
- Amlodipine Besylate and Benazepril Hydrochloride Capsules, Lupin, Ltd., Approval
- Balanced Salt Solution, B. Braun Medical, Inc., Approval
- Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Efficacy Supplement
- Cefoxitin and Dextrose in Plastic Container Injection, B. Braun Medical, Inc., Labeling Revision
- Cetirizine Hydrochloride Syrup, Actavis Mid Atlantic, LLC, Approval
- Children's Cetirizine Hydrochloride Allergy Syrup, Aurobindo Pharma, Ltd., Approval
- Children's Cetirizine Hydrochloride Hives Relief Syrup, Aurobindo Pharma, Ltd., Approval
- Chantix (varenicline tartrate) Tablets, Pfizer, Inc., Labeling Revision
- Claritin-D (loratadine and pseudoephedrine sulfate) Extended-Release Tablets, Schering-Plough, Labeling Revision
- Claritin-D 24 Hour (loratadine and pseudoephedrine sulfate) Extended-Release Tablets, Schering-Plough, Labeling Revision
- Didrex (benzphetamine hydrochloride) Tablets, Pharmacia & Upjohn Company, Labeling Revision
- Excedrin (Migraine) (acetaminophen, aspirin and caffeine) Tablets, Novartis Consumer Health, Inc., Labeling Revision
- Genotropin (somatropin [rDNA origin]) Injection, Pharmacia & Upjohn, Labeling Revision
- Labetalol Hydrochloride Injection, Sagent Strides, LLC, Approval
- Lamictal XR (lamotrigine) Extended-Release Tablets, GlaxoSmithKline, Approval
- Lamisil (terbinafine hydrochloride) Topical Solution, Novartis Consumer Health, Inc., Labeling Revision
- Lanoxin, (digoxin) Tablets, GlaxoSmithKline, Labeling Revision
- Lanoxin (digoxin) Injection, GlaxoSmithKline, Labeling Revision
- Levetiracetam Tablets, Taro Pharmaceuticals, Approval
- Norethindrone and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval
- Norvir (ritonavir) Tablets, AbbotLaboratories, Approval
- Norvir (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Prepidil (dinoprostone) Cervical Gel, Pfizer Global Pharmaceuticals, Labeling Revision
- Savella (milnacipran hydrochloride) Tablets, Cypress Bioscience, Inc., Labeling Revision
- Xiaflex (collagenase clostridium histolyticum) Injection, Auxilium Pharmaceuticals, Inc., Approval
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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
- AASLD/FDA/PhRMA Drug-Induced Liver Injury: Getting the Medicine and Science Together, March 24-25, 2010, Silver Spring, 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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- Menveo
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Posted: 2/19/2010
- Pediarix
Updated Package Insert, Posted: 2/19/2010
- Antihemophilic Factor
Recombinate, Antihemophilic Factor (Recombinant), Posted: 2/19/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Medical Officer (Supervisory), OC, Posted: 2/18/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Administrative Support Assistant, OVRR/DVRPA/RMSB, Posted: 2/18/2010
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot release information, Updated: 2/17/2010
- 2010 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
Draft Agenda, Member Roster, Posted: 2/17/2010
- Recall of Influenza A (H1N1) 2009 Monovalent Vaccine
Posted: 2/17/2010
- Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine in Prefilled Syringes
Posted: 2/17/2010
- Mathematical Statistician
OBE, Posted: 2/16/2010
- The 13th US-Japan Cellular and Gene Therapy Conference on Systems Biology in Cell Cycle Regulation
Posted: 2/16/2010
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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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PROPOSED RULES |
Reporting Information
Regarding Falsification of
Data
74127426 [20103123]
[TEXT] [PDF]
|
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NOTICES
|
Statement of Organizations,
Functions, and Delegations
of Authority
Office of the Commissioner Reorganization
74907512 [20103161]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Agreement for Shipment of Devices for Sterilization
72767277 [20103027]
[TEXT] [PDF]
Antimicrobial Animal Drug Distribution Reports Under
Section 105 of the Animal
Drug User Fee Amendments (of
2008)
72727274 [20103029]
[TEXT] [PDF]
Exception From General Requirements for Informed
Consent
72787279 [20103025]
[TEXT] [PDF]
Guidance for Humanitarian Device Exemption Holders,
Institutional Review Boards,
Clinical Investigators, and
FDA Staff, etc.
72707272 [20103030]
[TEXT] [PDF]
Guidance for Industry on How to Submit a Protocol
Without Data in Electronic
Format to the Center for
Veterinary Medicine
72777278 [20103026]
[TEXT] [PDF]
Guidance on Consultation Procedures: Foods Derived From
New Plant Varieties
72747276 [20103028]
[TEXT] [PDF]
Registration and Product Listing for Owners and
Operators of Domestic
Tobacco Product
Establishments, etc.
72697270 [20103031]
[TEXT] [PDF]
Tobacco Product Standard on Flavored Cigarettes
72797281 [20103036]
[TEXT] [PDF]
Meetings:
Circulatory System Devices Panel of the Medical Devices
Advisory Committee
72827283 [20103032]
[TEXT] [PDF]
Pediatric Advisory Committee
72817282 [20103024]
[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
- NONE |
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RULES
- NONE |
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NOTICES
- NONE |
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