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Center for Drug Evaluation &
Research (CDER) News
Drug
Approvals -
Meetings
-
Links |
Center for Biologics Evaluation
& Research (CBER)
Meetings
-
Links |
Center for Device &
Radiological Health (CDRH)
Meetings
-
Links |
Federal Register - Meetings,
Notices, & Rule Changes |
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CDER NEWS |
April 5, 2010
April 2, 2010
March 31, 2010
March 30, 2010
March 29, 2010
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April 2, 2010
- Advicor (niacin and lovastatin) Extended-Release Tablets, Abbott Laboratories, Manufacturing Change or Addition
- Metaxalone Tablets, Sandoz, Inc., Approval
- Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Ltd., Efficacy Supplement with Clinical Data to Support
- Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision
- Taclonex (calcipotriene and betamethasone dipropionate) Ointment, LEO Pharmaceuticals Products, Ltd., Labeling Revision
- Verelan (verapamil hydrochloride) Extended-Release Capsules, Elan Drug Delivery, Inc., Labeling Revision
- Vusion (miconazole nitrate, zinc oxide and white petrolatum) Ointment, Stiefel Laboratories, Inc., Labeling Revision
April 1, 2010
- Abacavir Sulfate and LamivudineTablets, Teva Pharmaceuticals, Tentative Approval
- Asclera (polidocanol) Injection, Chemische Fabrik Kreussler & Co., Approval
- Clindamycin Phosphate Foam, Cobrek Pharmaceuticals, Inc., Approval
- Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Isoptin SR (verapamil hydrochloride) Extended-Release Tablets, Ranbaxy Laboratories Ltd., Labeling Revision
- Moexipril Hydrochloride Tablets, Glenmark Generics Ltd., Approval
March 31, 2010
- Arixtra (fondaparinux sodium) Subcutaneous Injection, GlaxoSmithKline, Labeling Revision
- Benztropine Mesylate Injection, PharmaForce, Inc., Approval
- Benztropine Mesylate Tablets, InvaGen Pharmaceuticals Inc., Approval
- Isentress (raltegravir potassium) Tablets, Merck Sharp Dohme, Labeling Revision
- Lotrel (amlodipine besylate and benazapril hydrochloride) Capsules, Novartis Pharmaceuticals Corp., Labeling Revision
- Neomycin Sulfate Tablets, Oman Pharmaceutical Products Co. LLC, Approval
March 30, 2010
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-
4th
Annual
FDA/DIA
Statistics
Forum,
April
19-21,
2010,
Bethesda,
MD.
Meeting
information
and
registration
-
2010
PDA/FDA
Pharmaceutical
Supply
Chain
Workshop
- Enough
Talk:
Let's
Find and
Implement
Solutions,
April
26-28,
2010,
Hyatt
Regency
Bethesda,
7400
Wisconsin
Ave, 1
Bethesda
Metro
Center,
Bethesda,
MD
20814.
Meeting
information
and
registration
-
Public Hearing on Expanded Access of Direct-Acting Antiviral Agents (DAAs) for the Treatment of Chronic Hepatitis C Infection in Patients with Unmet Medical Need, April 30, 2010, Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852. Meeting information
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FDA and
PAT for
Pharma
Manufacturing:
FDA-Partnering
with
Industry;
a joint
FDA/URI
College
of
Pharmacy
conference,
Bethesda,
Maryland,
Hyatt
Regency
Bethesda,
May
11-12,
2010.
Meeting
information
and
registration
-
FDA
Orphan
Drugs
Workshops,
February
25-26,
2010,
Claremont,
CA;
August
3-4,
2010,
Minneapolis,
MN.
Meeting
Brochure
(PDF -
91 KB)
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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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CBER NEWS |
- Zemaira (Alpha1 Proteinase Inhibitor (Human)) Untitled Letter
March 5, 2010
Posted: 4/2/2010
- Prolastin (Alpha1 Proteinase Inhibitor (Human)) Untitled Letter
March 5, 2010
Posted: 4/2/2010
- Hizentra
Approval History, Letters, Reviews, and Related Documents, Posted: 4/2/2010
- March 18, 2010 Approval Letter - Menveo
To revise the instructions for use on the packing carton and vials.
Posted: 4/2/2010
- 2010 Biological License Application Supplement Noteworthy Approvals
Posted: 4/1/2010
- 2010 Biological Device Application Approvals
Updated: 4/1/2010
- 2010 Biological License Application Approvals
Updated: 4/1/2010
- Final Rule - Revision of Organization and Conforming Changes to Regulations
Posted: 4/1/2010
- Final Rule - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment.
Posted: 4/1/2010
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Posted: 4/1/2010
- Proposed Rule - Revision of the Requirements for Constituent Materials
Posted: 3/30/2010
- Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop
Posted: 3/30/2010
- Quantitative Risk Assessment: Blood Safety and Availability Public Workshop
Posted: 3/30/2010
- Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner.
Proposed Rule
Posted: 3/29/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Contract Specialist (Direct Hire), Posted: 3/29/2009
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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
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 - NONE |
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NOTICES
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Meetings:
National Antimicrobial Resistance Monitoring System
16817 [20107496]
[TEXT] [PDF]
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RULES |
Medical Devices; Pediatric
Uses of Devices:
Requirement for Submission of Information on Pediatric
Subpopulations That Suffer
From a Disease, et al.
1634716351 [20107193]
[TEXT] [PDF]
Ophthalmic and Topical
Dosage Form New Animal
Drugs:
1634616347 [20107163]
[TEXT] [PDF]
Revision of Organization and
Conforming Changes to
Regulations
1635316357 [20107282]
[TEXT] [PDF]
Technical Amendments:
Administrative Practices and Procedures; Good Guidance
Practices
1634516346 [20107286]
[TEXT] [PDF]
Medical Devices
1635116353 [20107288]
[TEXT] [PDF]
PROPOSED RULES
Beverages:
Bottled Water; Reopening of Comment Period
1636316365 [20107292]
[TEXT] [PDF]
Medical Devices;
Requirement for Submission of Information on Pediatric
Subpopulations That Suffer
From a Disease, etc.
1636516370 [20107192]
[TEXT] [PDF]
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NOTICES - NONE |
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RULES |
New Animal Drugs:
Removal of Obsolete and Redundant Regulations
1600116002 [20107108]
[TEXT] [PDF]
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Export of Food and Drug Administration Regulated
Products; Export
Certificates
1613716138 [20107111]
[TEXT] [PDF]
Meetings:
Anti-Infective Drugs Advisory Committee
1614816149 [20107113]
[TEXT] [PDF]
Antiviral Drugs Advisory Committee
16151 [20107114]
[TEXT] [PDF]
Public Workshop:
Pharmaceutical Supply Chain
1615716158 [20107151]
[TEXT] [PDF]
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RULES |
New Animal Drugs for Use in
Animal Feeds; CFR Correction
15610 [20107095]
[TEXT] [PDF]
PROPOSED RULES
Revisions of Requirements
for Constituent Materials
1563915642 [20107073]
[TEXT] [PDF]
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NOTICES |
Meetings:
Voting and Nonvoting Consumer Representative Members on
Public Advisory Committees
and Panels
15714 [20106967]
[TEXT] [PDF]
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RULES |
Advisory Committees;
Technical Amendment
1534215343 [20106861]
[TEXT] [PDF]
PROPOSED RULES
Direct-to-Consumer
Prescription Drug
Advertisements:
Presentation of the Major Statement in Television and
Radio Advertisements in a
Clear, Conspicuous, and
Neutral Manner
1537615387 [20106996]
[TEXT] [PDF]
Veterinary Feed Directive
1538715388 [20106872]
[TEXT] [PDF]
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NOTICES |
Food and Drug
Administration/Xavier
University Global Medical
Device Conference
1543915440 [20106865]
[TEXT] [PDF]
Guidance for Industry:
Standards for Securing the Drug Supply Chain
Standardized Numerical
Identification for
Prescription Drug Packages
1544015441 [20106863]
[TEXT] [PDF]
Public Workshops:
Advancing the Development of Diagnostic Tests and
Biomarkers for Tuberculosis
1544315444 [20106864]
[TEXT] [PDF]
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- April 05, 2010 -
FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery
- April 05, 2010 -
Federal Government Seizes Dozens of Misbranded Drug Products
- April 01, 2010 -
Federal Government Seeks Permanent Injunction Against Texas Egg Roll
Manufacturer
- March 31, 2010 -
FDA Requires Device Manufacturers to Include Information on Pediatric
Populations
- March 30, 2010 -
FDA Approves Asclera to Treat Small Varicose Veins
- March 27, 2010 -
Public Health Agencies Collaborate to Prevent Further Illnesses from
Norovirus Outbreak Associated with Oysters Recently Harvested from Area Near
Port Sulphur, La.
- March 26, 2010 -
Public Health Agencies Warn of Outbreaks Related to Drinking Raw Milk
- March 26, 2010 -
FDA Takes Action Against New York Dairy Farmer
- March 25, 2010 -
Two Arrested for Illegally Trafficking Counterfeit Weight Loss Medication
- March 25, 2010 -
FDA Approves New Use of Xifaxan for Patients with Liver Disease
- March 22, 2010 -
Obstetrics Manager Convicted of Tampering with Patient's Narcotics Medicines
at White Salmon Hospital
- March 22, 2010 -
U.S. Attorney News Release: Three Indicted for Diversion of Prescription
Drugs
- March 22, 2010 -
Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety
Risk
- March 21, 2010 -
U.S. Attorney News Release: Springfield (Missouri) Business Owner Pleads
Guilty to $17 Million Fraud Scheme
- March
19, 2010 -
FDA Warns about Increased Risk of Muscle Injury with Zocor
- March
18, 2010 -
FDA Approves Drug to Treat Condition That Causes Elevated Ammonia Levels
- March
17, 2010 -
Statement for National Poison Prevention Week
- March
17, 2010 -
FDA Approves First Totally Implanted Hearing System
- March
17, 2010 -
FDA March 17 Update on the Investigation into the Salmonella Montevideo
Outbreak
- March
17, 2010 -
FDA Seeks Permanent Injunction Against Louisiana Sprout Grower
- March
16, 2010 -
FDA Orders 2 Companies to Stop Marketing Unapproved Nitroglycerin Tablets
- March
12, 2010 -
FDA Announces New Boxed Warning on Plavi
- March
12, 2010 -
FDA Task Force Seeks Public Comments on Increasing Transparency with
Regulated Industry
- March
11, 2010 -
FDA Issues Warning on Counterfeit Surgical Mesh
- March
11, 2010 -
FDA March 11 Update on the Investigation into the Salmonella Montevideo
Outbreak
- March
09, 2010 -
FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist
and Finge
- March
05, 2010 -
FDA Update on the Investigation into the Salmonella Montevideo Outbreak -
March 5, 2010
- March
04, 2010 -
FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor
Enhancers for Food Processors and Other Distributors
- March
04, 2010 -
FDA Approves Name Change for Heartburn Drug Kapidex
- March
03, 2010 -
La FDA advierte a los consumidores en Puerto Rico acerca de la presencia de
una bacteria daρina en desinfectantes para manos
- March
03, 2010 -
FDA Warns Consumers in Puerto Rico of Harmful Bacteria in Hand Sanitizers
- March
03, 2010 -
FDA, FSIS, CDC Collaborate on Methods to Measure Success of Food Safety
Programs
- March
03, 2010 -
FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner
Issues an Open Letter to the Industry
- March
02, 2010 -
FDA Survey Finds More Americans Read Information on Food Labels
- March
02, 2010 -
FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
- March
02, 2010 -
U.S. Attorney News Release: Boca Raton Man Sentenced for Nutritional
Supplement Scam
- March
01, 2010 -
FDA Announces Meeting Information and Voting Membership of the Tobacco
Products Scientific Advisory Committee
- February 26, 2010 -
International Collaboration: FDA and European Medicines Agency Agree to
Accept a Single Orphan Drug Designation Annual Report
- February 26, 2010 -
FDA Update on the Investigation into the Salmonella Montevideo Outbreak -
February 26, 2010
- February 26, 2010 -
FDA Approves Therapy to Treat Gaucher Disease
- February 26, 2010 -
U.S. Attorney News Release: Medical Device Manufacturer Guidant Charged in
Failure to Report Defibrillator Safety
- February 25, 2010 -
FDA Update on the Investigation into the Salmonella Montevideo Outbreak -
February 25, 2010
- February 25, 2010 -
U.S. Attorney News Release: Medical Technician Sentenced to 30 Years
- February 24, 2010 -
FDA Approves Pneumococcal Disease Vaccine with Broader Protection
- February 24, 2010 -
NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to
the Public
- February 23, 2010 -
U.S. Attorney News Release: Woman pleads guilty to poisoning salsa at Lenexa
restaurant
- February 23, 2010 -
FDA Announces Possible Safety Concern for HIV Drug Combination
- February 23, 2010 -
Maryland Veal Calf Dealer Agrees to Close in Response to FDA-Initiated
Action
- February 19, 2010 -
Regulatory Science Update: FDA and International Serious Adverse Events
Consortium Complete Third Data Release
- February 19, 2010 -
U.S. Attorney New Release: Miami Prescription Drug Diverter Sentenced To 70
Months In Prison
- February 19, 2010 -
U.S. Attorney New Release: SK Foods former owner charged with RICO
violations
- February 18, 2010 -
FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
- February 18, 2010 -
FDA Cancer Drug Approval Rate Highlighted in JNCI
- February 18, 2010 -
USDA and FDA Coordinating Efforts to Ensure Safety of Produce
- February 18, 2010 -
FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications
Used to Treat Asthma
- February 17, 2010 -
FDA Warns about Serious Side Effects from Maalox Product Mix-Ups
- February 17, 2010 -
FDA Update on the Investigation into the Salmonella Montevideo Outbrea
- February 16, 2010 -
FDA Announces New Safety Plan for Agents Used to Treat Chemotherapy-Related
Anemia
- February 12, 2010 -
U.S. Attorney News Release: Company pleads guilty to felony misbranding of a
drug
- February 12, 2010 -
U.S. Attorney News Release: Subject sentenced to 51 months for sale of
unapproved medical devices
- February 12, 2010 -
U.S. Attorney New Release: Business Owner Pleads Guilty to Fraudulently
Marketing Dietary Supplements
- February 09, 2010 -
FDA Approves New Indication for Crestor
- February 09, 2010 -
FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical
Imaging
- February 08, 2010 -
FDA Updates Statement on the Investigation into the Salmonella Montevideo
Outbreak
- February 05, 2010 -
FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
- February 03, 2010 -
United States Seizes more than 1500 Cases of Food from Wisconsin
Distribution Warehouse
- February 02, 2010 -
FDA Approves Xiaflex for Debilitating Hand Condition
- February 01, 2010 -
FDA Requests $4.03 Billion to Transform Food Safety System, Invest in
Medical Product Safety, Regulatory Science
- February 01, 2010 -
FDA Announces Safety Risk Associated with HIV Drug
- February 01, 2010 -
FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for
Children in Developing Countries
- 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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