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Center
for Drug Evaluation &
Research (CDER) News
Drug Approvals -
Meetings
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Links |
Center
for Biologics Evaluation
&
Research (CBER)
Meetings
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Links |
Center
for Device &
Radiological
Health (CDRH)
Meetings
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Links |
Federal Register -
Meetings, Notices, & Rule Changes |
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February 5, 2010
February 4, 2010
February 3, 2010
February 2, 2010
February 1, 2010
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February 4, 2010
- Accutane (isotretinoin) Capsules, Hoffmann-La Roche Inc., Labeling Revision
- Cancidas (caspofungin acetate) I.V. Injection, Merck Research Laboratories, Labeling Revision
- Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
- Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Kenalog-10 (triamcinolone acetonide) Injection, Apothecon Inc., Labeling Revision
- Kenalog-40 (triamcinolone acetonide) Injection, Apothecon Inc., Labeling Revision
- Oleptro (trazodone hydrochloride) Extended-Release Tablets, Labopharm Canada, Approval
- Olopatadine Hydrochloride Ophthalmic Solution, Sandoz Inc., Tentative Approval
- PEG 3350 and Electrolytes (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous) Oral Solution, Mylan Pharmaceuticals Inc., Approval
- Pexeva (paroxetine mesylate) Tablets, Noven Therapeutics, LLC, Labeling Revision
- Prezista (darunavir ethanolate) Tablets, Tibotec Inc., Efficacy Supplement
February 2, 2010
- Cefotaxime Sodium Injection, Cephazone Pharma LLC, Approval
- Granisetron Hydrochloride Injection, West-Ward Pharmaceutical Corp., Approval
- Lorazepam Oral Concentrate, Amneal Pharmaceuticals, Approval
- Orfadin (nitisinone) Capsules, R & R Registrations, Labeling Revision
- Sandostatin (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
- Sandostatin LAR (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
- Zoledronic Acid Injection, Hospira, Inc., Tentative 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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- Waivers for Conflicts of Interest for the February 22, 2010 Vaccines and Related Biological Products Advisory Committee Meeting
There are no Waivers for Conflicts of Interest, Posted: 2/5/2010
- Recall: Y-Type Blood Solution Sets
Baxter, Posted: 2/5/2010
- Complete List of Licensed Products and Establishments
Updated: 2/4/2010
- Biologic Product Shortages
Updated PedvaxHIB & Comvax information; Updated: 2/4/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Postdoctoral Fellowship, OBRR/DH/LBVB, Posted: 2/3/2010
- Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 796KB)
Updated: 2/3/2010
- Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 171KB)
Updated: 2/3/2010
- Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 36KB)
Updated: 2/3/2010
- Black Widow Spider Antivenin (Equine)
Added Package Insert to product page, Posted: 2/3/2010
- Atgam
Added Package Insert to product page, Posted: 2/3/2010
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Updated: 2/2/2010
- Botulism Antitoxin Bivalent (Equine) Types A and B
Added Package Insert to product page, Posted: 2/2/2010
- Vaccinia Immune Globulin Intravenous (Human)
Revised Package Inserts, Updated: 2/1/2010
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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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February 5, 2010
February 4, 2010
February 2, 2010
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-
The A to Z of Off Label
Issues, February 9, 2010
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Public Meeting:
Incorporation of New
Science Into Regulatory
Decision-making Within
the Center for Devices
and Radiological Health
- February 9, 2010
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510(k) Submissions - The
Course for Beginning RA
Professionals for
Preparing a 510(k),
February 22-23, 2010
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Investigational Device
Exemption (IDE)
Submission Workshop,
February 24, 2010
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PMA Submissions
Workshop, February
25-26, 2010
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FDA/CDRH Public Meeting:
Blood Glucose Meters -
March 16-17, 2010
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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 |
Listing of Color Additives
Exempt From Certification:
Astaxanthin Dimethyldisuccinate; Confirmation of
Effective Date
5887 [20102522]
[TEXT] [PDF]
Paracoccus Pigment; Confirmation of Effective Date
5887 [20102521]
[TEXT] [PDF]
New Animal Drugs for Use in
Animal Feeds:
Ractopamine; Monensin
58875888 [20102427]
[TEXT] [PDF]
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
60366037 [20102458]
[TEXT] [PDF]
6035 [20102459]
[TEXT] [PDF]
60346035 [20102461]
[TEXT] [PDF]
60386039 [20102523]
[TEXT] [PDF]
60376038 [20102527]
[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 |
Debarment Order:
Brian Ullom
5332 [20102135]
[TEXT] [PDF]
Meetings:
Endocrinologic and Metabolic Drugs Advisory Committee;
Cancellation
5333 [20102096]
[TEXT] [PDF]
Pulmonary-Allergy Drugs Advisory Committee
53335334 [20102054]
[TEXT] [PDF]
53345335 [20102097]
[TEXT] [PDF]
Risk Communication Advisory Committee
5335 [20102053]
[TEXT] [PDF]
Public Workshops:
Pediatric Neurological and Neurocognitive Assessments
for Cardiovascular Devices
53355336 [20102110]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES
- NONE |
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- January 29, 2010 -
FDA Statement on the Investigation into the Salmonella Montevideo Outbreak
- January 29, 2010 -
FDA Expands Use of Approved Breast Cancer Drug
- January 29, 2010 -
United States Seizes Unapproved Ozone Generators
- January 26, 2010 -
FDA Announces Class I Recall of Certain Infusion Set Needles
- January 26, 2010 -
FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic
Pain
- January 25, 2010 -
FDA Approves New Treatment for Type 2 Diabetes
- January 25, 2010 -
FDA Approves First Percutaneous Heart Valve
- January 22, 2010 -
FDA Schedules Public Meeting on Premarket Clearance Process for Medical
Devices
- January 22, 2010 -
FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
- January 20, 2010 -
FDA Approves Left Ventricular Assist System for Severe Heart Failure
Patients
- January 19, 2010 -
U.S. Attorney New Release: Bellevue, Washington Salon Owner Sentenced in
Connection with Unlicensed Cosmetic Treatments
- January 18, 2010 -
FDA Warns Consumers about Counterfeit Alli
- January 15, 2010 -
FDA Commissioner Addresses Nation's Health Care Professionals on H1N1
Vaccine Safety
- January 15, 2010 -
U.S. Attorney New Release: Anesthesiologist Charged With Falsifying Medical
Research
- January 14, 2010 -
FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and
Distributed by Merrick Pet Care
- January 14, 2010 -
FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler
- January 13, 2010 -
FDA Issues Consumer Alert on HAPPYTOT Stage 4 and Some HAPPYBABY Stage 1 &
Stage 2 Baby Foods
- January 13, 2010 -
U.S. Attorney News Release: Longmont, Colorado Man Arrested For Removing And
Replacing Labels On Gatorade Bottles
- January 12, 2010 -
FDA Unveils First Phase of Transparency Initiative
- January 11, 2010 -
FDA Approves New Drug for Rheumatoid Arthritis
- January 08, 2010 -
FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety
Monitoring System
- January 08, 2010 -
FDA Ends Maryland Seafood Processors Pattern of Sanitary Violations
- January 08, 2010 -
FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices
- January 06, 2010 -
FDA Seizes More Than $1 Million Worth of Food from Nashville Food Processor
and Warehouse: Agency acts to prevent distribution of food from
rodent-infested facility
- January 04, 2010 -
FDA Takes Action Against New Jersey Cheese Manufacturer
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