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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

CDER NEWS

March 5, 2010

Guidance for Industry: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 170 KB)
Office of Nonprescription Products Consumer Update: Hydroquinone Studies Under The National Toxicology Program (NTP)
Rulemaking History for Nonprescription Products: Acne

March 4, 2010

March 3, 2010

March 2, 2010

Drug Shortages: Current Drug Shortages: Cerezyme (imiglucerase) Injection

March 1, 2010

Drug Approvals

March 5, 2010

Adalat (nifedipine) Extended-Release Tablets, Bayer HealthCare, Labeling Revision
Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
ChloraPrep One-Step Sepp (chlorhexidine gluconate and isopropyl alcohol) Topical Swab, CareFusion, LLC, Labeling Revision
Femara (letrozole) Tablets, Novartis Pharmaceuticals Corporation, Efficacy Supplement with Clinical Data to Support
Fluvastatin Capsules, Teva Pharmaceuticals, Tentative Approval
Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical, Labeling Revision
Levetiracetam Oral Solution, Wockhardt, Approval
Rapaflo (silodosin) Capsules, Watson Laboratories, Inc., Labeling Revision
Xifaxan (rifaximin) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
Zocor (simvastatin) Tablets, Merck & Co., Inc., Labeling Revision

March 3, 2010

Exalgo (hydromorphone hrdrochloride) Extended-Release Tablets, ALZA Corporation, Approval
Fosamax (alendronate sodium) Tablets, Merck & Co., Inc., Labeling Revision
Fosamax (alendronate sodium) Oral Solution, Merck & Co., Inc., Labeling Revision
Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck & Co., Inc., Labeling Revision
Norditropin (somatropin [rDNA origin]) Injection, Novo Nordisk Inc., Manufacturing Change or Addition
Tamsulosin Hydrochloride Capsules, IMPAX Laboratories, Inc., Approval
Temozolomide Capsules, Barr Laboratories, Inc., Approval

March 2, 2010

Articaine Hydrochloride and Epinephrine Injection, TechReg Services, Inc., Approval
Cefoxitin Injection, West-Ward Pharmaceutical Corp., Approval
Hydralazine Hydrochloride Tablets, Zydus Pharmaceuticals USA, Approval
Janumet (metformin hydrochloride and sitagliptin phosphate) Tablets, Merck, Efficacy Supplement with Clinical Data to Support
Januvia (sitagliptin phosphate) Tablets, Merck Co. Inc., Efficacy Supplement with Clinical Data to Support
Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, Biovail Technologies, Ltd., Labeling Revision
Vpriv (velaglucerase alfa) Injection, Shire Human Genetic Therapies, Inc., Approval
Zyban (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
Zyrtec Allergy (cetirizine hydrochloride) Tablets, McNeil Consumer Healthcare, Labeling Revision

March 1, 2010

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Sandoz Inc., Tentative Approval
Glumetza (metformin hydrchloride) Extended-Release Tablets, DepoMed, Inc., Labeling Revision
Hydrocodone Bitartrate and Acetaminophen Oral Solution, Mikart Inc., Approval
Lax-Lyte with Flavor Packs (Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride) Oral Solution, Paddock Laboratories, Inc., Approval
Rocephin (ceftriaxone sodium) Intramuscular I.V. Injection, Hoffmann-La Roche, Inc., Labeling Revision
Ropinirole Hydrochloride Tablets, Glenmark Generics Ltd., Approval
Treanda (bendamustine hydrochloride) I.V. Powder, Cephalon Inc., Labeling Revision

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

Workshops, Meetings & Conferences (Biologics)
DIA/FDA CDER/CBER Computational Science Annual Meeting, Posted: 3/4/2010
Hizentra
Product approval, Posted: 3/4/2010
BCG Vaccine
Package Insert posted, Updated: 3/4/2010
Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Updated: 3/3/2010
Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (PDF - 406KB)
Posted: 3/2/2010
Influenza Virus Vaccine for the 2010-2011 Season
Posted: 3/2/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary Scientist, OCTGT, Posted: 3/2/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Supervisory Contract Specialist (Direct Hire), Posted: 3/2/2010

CBER Meetings

Cord Blood Licensure: A Workshop
March 8 - 9, 2010; Rockville, MD
DIA/FDA CDER/CBER Computational Science Annual Meeting
March 22 - 23, 2010; Bethesda, MD

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

March 5, 2010

March 3, 2010

Class I Medical Device Recall: Baxter HomeChoice and HomeChoice PRO

March 2, 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 - Friday - 520, 522, 524, 526
Thursday - 333
Tuesday - 522, 558

Fri, March 05, 2010

RULES - NONE

New Animal Drugs:
Change of Sponsor
10165–10168 [2010–4560] [TEXT] [PDF]

NOTICES

Meetings:
Strengthening the Center for Devices and Radiological Health's 510(k) Review Process
10294–10295 [2010–4662] [TEXT] [PDF]

Thurs, March 04, 2010

RULES - NONE

Topical Acne Drug Products for Over-The-Counter Human Use:
Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format
9767–9777 [2010–4424] [TEXT] [PDF]

NOTICES - NONE

Denial of Hearing; Final Debarment Order:
     James A. Holland
     9904–9905 [2010–4449]   [TEXT]  [PDF]

Guidance For Industry:
     Characterization and Qualification of Cell Substrates and Other Biological Materials, etc.
     9905–9906 [2010–4553]   [TEXT]  [PDF]

Wed, March 03, 2010

RULES - NONE

NOTICES

Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Manufactured Food Regulatory Program Standards
9605 [2010–4340] [TEXT] [PDF]

Tue, March 02, 2010

RULES - NONE

Implantation or Injectable Dosage Form New Animal Drugs:
     Tilmicosin
     9333–9334 [2010–4206]   [TEXT]  [PDF]

New Animal Drugs for Use in Animal Feeds:
     Chlortetracycline
     9334 [2010–4205]   [TEXT]  [PDF]

NOTICES

Advisory Committee Information Hotline
9416–9418 [2010–4258]   [TEXT]  [PDF]

Meetings:
     Oncologic Drugs Advisory Committee
     9419–9420 [2010–4261]   [TEXT]  [PDF]
     Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
     9422–9423 [2010–4260]   [TEXT]  [PDF]
     Pulmonary-Allergy Drugs Advisory Committee
     9420 [2010–4262]   [TEXT]  [PDF]
     Tobacco Products Scientific Advisory Committee
     9422 [2010–4195]   [TEXT]  [PDF]

Mon, March 01, 2010

RULES

NOTICES

Agency Information Collection Activities; Proposals, Submissions, and Approvals:
     Human Tissue Intended for Transplantation
     9226–9227 [2010–4066]   [TEXT]  [PDF]
     Pretesting of Tobacco Communications
     9225–9226 [2010–4098]   [TEXT]  [PDF]

Determinations of Regulatory Review Periods for Purposes of Patent Extensions:
     Firmagon
     9227–9228 [2010–4159]   [TEXT]  [PDF]

Draft Guidance for Industry:
     Non-Inferiority Clinical Trials; Availability
     9228–9229 [2010–4109]   [TEXT]  [PDF]

Public Workshop:
     Measuring Progress on Food Safety: Current Status and Future Directions
     9232–9233 [2010–4110]   [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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March 5, 2010

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FDA Press Announcement - Back to top