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GXPNews.com - FDA News and Announcements - February 22 - February 26, 2010

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& Research (CBER)
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CDER NEWS

February 26, 2010

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
Guidance for Industry: Non-Inferiority Clinical Trials (PDF - 565 KB)

February 25, 2010

February 24, 2010

February 23, 2010

FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms
Paragraph IV Patent Certifications

February 22, 2010

Drug Approvals

February 25, 2010

Bystolic (nebivolol hydrochloride) Tablets, Forest Laboratories, Inc., Efficacy Supplement
Cayston (aztreonam) Inhalation Solution, Gilead Sciences, Inc., Approval
Cefoxitin and Dextrose in Duplex Container Injection, B. Braun Medical, Inc., Labeling Revision
Cyanokit (hydroxocobalamin) Injection, Merck Sante s.a.s., Labeling Revision
Dyazide (hydrochlorothiazide and triamterene) Capsules, GlaxoSmithKline, Labeling Revision
Finasteride Tablets, Accord Healthcare, Inc., Approval
Forane (isoflurane) Inhalation Liquid, Baxter Healthcare Corporation, Labeling Revision
Imiquimod Cream, Nycomed, Inc., Approval
Intelence (etravirine) Tablets, Tibotec, Inc., Labeling Revision
Marcaine (bupivacaine hydrochloride) Injection, Hospira, Inc., Labeling Revision
Marcaine (bupivacaine hydrochloride) Injection, Hospira, Inc., Labeling Revision
Naratripta Tablets, Roxane Laboratories, Inc., Tentative Approval
Niaspan (niacin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
Norethindrone and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval
Polyethylene Glycol 3350 and Electrolytes Oral Solution, Paddock Laboratories, Approval
Rocaltrol (calcitriol) Capsules, Validus Pharmaceuticals, Labeling Revision
Septocaine (articaine hydrochloride and epinephrine) Injection, Deproco, Inc., Labeling Revision
Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision and Efficacy Supplement
Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-La Roche, Inc., Labeling Revision and Efficacy Supplement
Tracleer (bosentan) Tablets, Actelion, Ltd., Labeling

February 24, 2010

Carbocaine (mepivacaine hydrochloride) Injection, Hospira, Inc., Labeling Revision
Desloratadine Tablets, Orchid Healthcare, Approval
Mirapex ER (pramipexole dihydrochloride) Extended-Release Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Approval
Naropin (ropivacaine hydrochloride monohydrate) Injection, APP Pharmaceuticals, Labeling Revision
Nesacaine (chloroprocaine hydrochloride) Injection, APP Pharmaceuticals, Labeling Revision
Xylocaine (lidocaine hydrochloride) Injection, APP Pharmaceuticals, Labeling Revision
Xylocaine 4% Preservative Free (lidocaine hydrochloride) Injection, APP Pharmaceuticals, Labeling Revision

February 23, 2010

Alendronate Sodium Tablets, Cadista Pharmaceuticals Inc., Approval
Baclofen Tablets, Matrix Laboratories Ltd., Approval
Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer, Inc., Labeling Revision
Ciclopirox Topical Solution, VersaPharm Inc., Approval
Coartem (artemether and lumefantrine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Donepezil Hydrochloride Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval
Metformin Hydrochloride Extended-Release Tablets, Torrent Pharmaceuticals Ltd., Approval

CDER Meetings

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 registrat
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

CDER Links

Guidance

Approved Drugs

Approval Process

Electronic Submissions

Firm Registration Status

Good Manufacturing Practice Regulations

National Drug Code Directory

MedWatch: Adverse Event Reporting

CBER NEWS

2009 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Updated: 2/26/2010
2009 Biological Device Application Approvals
Updated: 2/26/2010
2009 Biological License Application Supplement Noteworthy Approvals
Updated: 2/26/2010
2010 Biological Device Application Approvals
Updated: 2/26/2010
FluMist
Package Insert Updated, Posted: 2/26/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Nurse Consultant (Direct Hire), Posted: 2/26/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Analyst, OM/DPEB, Posted: 2/25/2010
Prevnar 13
Product Approval, Posted: 2/24/2010
Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Updated: 2/24/2010
Infanrix
Revise the Package Insert to add a warning regarding apnea in premature infants. Posted: 2/24/2010
ROTARIX
Revise the Contraindications section to include infants with Severe Combined Immunodeficiency Disease (SCID), Posted: 2/23/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Posted: 2/23/2010
FDA Public Health Notification: Newborn Blood Banking, Inc.
Posted: 2/23/2010
Order to Cease Manufacturing of HCT/Ps: Newborn Blood Banking, Inc.
Posted: 2/23/2010
NovoSevenRT
Package Insert Update, Posted: 2/23/2010
Biologics PREA Reviews and Labeling Changes
Menveo information added, Updated: 2/22/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Regulatory Information Specialist, OCBQ, Posted: 2/22/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Mathematical Statistician, General Register, Posted: 2/22/2010

CBER Meetings

The 13th US-Japan Cellular and Gene Therapy Conference on Systems Biology in Cell Cycle Regulation
February 25, 2010
Cord Blood Licensure: A Workshop
March 8 - 9, 2010

CBER Links

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.

CDRH NEWS

February 26, 2010

February 23, 2010

February 22, 2010

CDRH Meetings

CDRH Links

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

Weekly CFR Rule Changes - Monday - 558

Fri, February 26, 2010

RULES - NONE

NOTICES

Agency Information Collection Activities; Proposals, Submissions, and Approvals:
     Mental Models Study of Recruitment and Retention of Pregnant Women Into An Asthma Pregnancy Registry
     8957–8959 [2010–3912]   [TEXT]  [PDF]
     Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products
     8963–8966 [2010–4002]   [TEXT]  [PDF]
     Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
     8959–8960 [2010–3911]   [TEXT]  [PDF]
     Third Party Disclosure and Recordkeeping Requirements for Reportable Food
     8960–8963 [2010–4003]   [TEXT]  [PDF]

Draft Guidance for Industry:
     Adaptive Design Clinical Trials for Drugs and Biologics; Availability
     8968–8970 [2010–3980]   [TEXT]  [PDF]

Guidance for Industry on Submission of Documentation:
    Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
     8970–8971 [2010–3978]   [TEXT]  [PDF]

Thurs, February 25, 2010

RULES - NONE

NOTICES - NONE

Wed, February 24, 2010

RULES - NONE

NOTICES

Meetings:
     Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
     8368–8369 [2010–3594]   [TEXT]  [PDF]
     Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging; Request for Comments
     8375–8377 [2010–3674]   [TEXT]  [PDF]
     Pulmonary-Allergy Drugs Advisory Committee
     8377 [2010–3595]   [TEXT]  [PDF]

Tue, February 23, 2010

RULES - NONE

NOTICES

Debarment Orders:
     Patrick J. Lais
     8081–8082 [2010–3552]   [TEXT]  [PDF]

Preventive Controls for Fresh Produce; Request for Comments
8086–8087 [2010–3409]   [TEXT]  [PDF]

Mon, February 22, 2010

RULES

New Animal Drugs for Use in Animal Feeds:
Bacitracin Zinc; Nicarbazin
7555 [2010–3328] [TEXT] [PDF]

NOTICES

Agency Information Collection Activities; Proposals, Submissions, and Approvals:
     Experimental Study of Graphic Cigarette Warning Labels
     7604–7606 [2010–3320]   [TEXT]  [PDF]

Request for Environmental Impact Data and Information:
     Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human Use
     7606–7608 [2010–3319]   [TEXT]  [PDF]

FDA Press Announcement - Back to top
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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February 26, 2010

February 23, 2010

February 22, 2010

FDA Press Announcement - Back to top