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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
-
Links |
Center for Device &
Radiological Health (CDRH)
Meetings
-
Links |
Federal Register - Meetings,
Notices, & Rule Changes |
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CDER NEWS |
March 19,
2010
March 18,
2010
March 17,
2010
March 16,
2010
March 15,
2010
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March 19, 2010
- Carbaglu (carglumic acid) Tablets, R & R Registrations, Inc., Approval
- Differin (adapalene) Lotion, Galderma Research and Development, Inc., Approval
- Drospirenone and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Tentative Approval
- Indomethacin Injection, APP Pharmaceuticals, LLC, Approval
- MultiHance (gadobenate dimeglumine) Intravenous Injection, Bracco Diagnostics, Inc., Efficacy Supplement with Clinical Data to Support
- Norethindrone Acetate and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval
- Norethindrone Acetate, Ethinyl Estradiol and Ferrous Fumarate Tablets, Watson Laboratories, Inc., Approval
- Phentermine Hydrochloride Capsules, Barr Laboratories, Inc., Approval
- Silenor (doxepin hydrochloride) Tablets, Somaxon Pharmaceuticals, Inc., Approval
March 18, 2010
- Dacogen (decitabine) Intravenous Injection, Eisai Medical Research, Inc., Efficacy Supplement
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories, Approval
- Moexipril Hydrochloride and Hydrochlorothiazide Tablets, Glenmark Generics Inc., Approval
- Percodan (oxycodone hydrochloride and aspirin) Tablets, Endo Pharmaceuticals, Inc., Labeling Revision
- Promethazine Hydrochloride and Codeine Phosphate Syrup, SUN Pharmaceutical, Approval
March 17, 2010
- Alprazolam Orally Disintegrating Tablets, Actavis Elizabeth LLC, Approval
- Cardura XL (doxazosin mesylate) Extended Release Tablets, Pfizer, Inc., Labeling Revision
- Cefoxitin (cefoxitin sodium) Injection, Hikma Farmaceutica, Approval
- Diltiazem Hydrochloride Extended-Release Tablets, Watson Laboratories, Inc., Approval
- Levulan (aminolevulinic acid hydrochloride) Topical Solution, DUSA Pharmaceuticals, Inc., Efficacy Supplement with Clinical Data to Support
- Tasigna (nilotinib hydrochloride monohydrate) Capsules, Novartis Pharmaceuticals, Labeling Revision
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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
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4th
Annual
FDA/DIA
Statistics
Forum,
April
19-21,
2010,
Bethesda,
MD.
Meeting
information
and
registration
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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
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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
Español
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CBER NEWS |
- Tissue Reference Group
FY 2009 TRG Update, Posted: 3/19/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Supervisory Regulatory Information Specialist, OCOD/DCCA/CTB, Posted: 3/18/2010
- Menveo
Approval History, Letters, Reviews, and Related Documents, Posted: 3/17/2010
- April 12, 2010: Blood Products Advisory Committee Meeting Announcement
Posted: 3/17/2010
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Updated: 3/17/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Postdoctoral Fellowship, OBRR, Posted: 3/17/2010
- Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 185KB)
Updated: 3/15/2010
- Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 48KB)
Updated: 3/15/2010
- Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 885KB)
Updated: 3/15/2010
- Biologic Product Shortages
Updated: 3/15/2010
- Complete List of Licensed Products and Establishments
Updated: 3/15/2010
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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 |
Implantation or Injectable
Dosage Form New Animal
Drugs:
Flunixin
13225 [2010–6038]
[TEXT] [PDF]
Regulations Restricting the
Sale and Distribution of
Cigarettes and Smokeless
Tobacco To Protect Children
and Adolescents
13225–13232 [2010–6087]
[TEXT] [PDF]
PROPOSED RULES
Implementation of the Family
Smoking Prevention and
Tobacco Control Act; Request
for Comments
13241–13243 [2010–6086]
[TEXT] [PDF]
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NOTICES
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Determinations:
HalfLytely and Bisacodyl Tablets Bowel Prep Kit, et al.
13292 [2010–5979]
[TEXT] [PDF]
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RULES |
Oral Dosage Form New Animal
Drugs:
Tetracycline Powder; Technical Amendment
12981 [2010–5925]
[TEXT] [PDF]
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NOTICES - NONE |
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RULES - NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Abbreviated New Animal Drug Applications
12759–12760 [2010–5747]
[TEXT] [PDF]
Prescription Drug Advertisements
12756–12758 [2010–5812]
[TEXT] [PDF]
Product Jurisdiction; Assignment of Agency Component
for Review of Premarket
Applications
12758–12759 [2010–5749]
[TEXT] [PDF]
Determination:
CERNEVIT12 (Multivitamins for Infusion) Was Withdrawn
From Sale for Reasons of
Safety or Effectiveness
12760–12761 [2010–5748]
[TEXT] [PDF]
Meetings:
Anesthetic and Life Support Drugs Advisory Committee
and Drug Safety and Risk
Management Advisory
Committee
12767 [2010–5815]
[TEXT] [PDF]
Blood Products Advisory Committee
12768 [2010–5814]
[TEXT] [PDF]
Peripheral and Central Nervous System Drugs Advisory
Committee
12768–12769 [2010–5813]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Cosmetic Labeling Regulations
12546–12547 [2010–5657]
[TEXT] [PDF]
Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism
Preparedness and Response
Act (of 2002)
12549–12552 [2010–5655]
[TEXT] [PDF]
Registration of Food Facilities Under the Public Health
Security and Bioterrorism
Preparedness and Response
Act (of 2002)
12547–12549 [2010–5656]
[TEXT] [PDF]
Requirements Under the Comprehensive Smokeless Tobacco
Health Education Act of
1986, etc.
12552–12553 [2010–5654]
[TEXT] [PDF]
Meetings:
Prescription Drug User Fee Act
12555–12557 [2010–5664]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES - NONE |
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- 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 dañina 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 Processor’s 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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