GXPnews

If you are having problems viewing this page, load here

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

The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
Distributed by the leader in Federal Regulations, GMP Publications & FDA.COM - Feedback: GXPNews Editor


Drug GMP Handbooks \| Clinical Handbooks \| Device Handbooks \| Biological Handbooks GLP Master Handbook - Clinical Master Guide - Canadian GMPs - Pharmacovigilance Vol. 9a - Electronic Systems

GMP Publications FDA Mini-Regulation Handbooks

Last Chance! Save 10% on all Code of Federal Regulations (CFRs) Pre-Orders till April 1, 2010
Use Coupon Number 100401-10

FDA Press Announcements | S tay current with the FDA Rule Updates | Pick up your free CFRs at Interphex!

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 26, 2010

March 25, 2010

March 24, 2010

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
Pediatric Drug Development: Breakdown of FDAAA Completed Pediatric Studies

March 23, 2010

Upcoming FDA Basics Webinar:
FDA's Inspection Process hosted by FDA on Thursday, March 25, 2010, from 2:00 to 2:30 p.m. ET.
To read more about this free webinar, please visit http://www.fda.gov/AboutFDA
/Basics/ucm204963.htm
Drug Safety Oversight Board Meeting, Public Summary, February 18, 2010
Drug Shortages: Current Drug Shortages: Acyclovir Tablets and Capsules
Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection)
Drug Shortages: Current Drug Shortages: Mitomycin for injection

March 22, 2010

Drug Approvals

March 26, 2010

Argatroban Injection, Pliva Hrvatska, Tentative Approval
Kapidex (dexlansoprazole) Delayed-Release Capsules, Takeda Global Research & Development Center, Inc., Labeling Revision
Propecia (finasteride) Tablets, Merck & Co., Inc., Labeling Revision
Relenza (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
Xifaxan (rifaximin) Tablets, Salix Pharmaceuticals, Approval

March 25, 2010

Calcipotriene Ointment, Glenmark Generics Inc., Approval
Emend (fosaprepitant dimeglumine) I.V. Powder, Merck & Co., Inc., Labeling Revision
Fluoxetine Delayed-Release Capsules, Barr Laboratories, Inc., Approval
Pepcid (famotidine) Tablets, Merck & Co., Inc., Labeling Revision
Proscar (finasteride) Tablets, Merck & Co., Inc., Labeling Revision
Ropinirole Hydrochloride Tablets, Alembic Limited, Approval

March 24, 2010

Donepezil Hydrochloride Tablets, Zydus Pharmaceuticals USA Inc., Tentative Approval
Emend (aprepitant) Capsules, Merck Sharp & Dohme Corp., Efficacy Supplement with Clinical Data to Support
Fluoxetine Hydrochloride Delayed-Release Capsules, Dr. Reddy's Laboratories Ltd., Approval
Kapidex (dexlansoprazole) Delayed Release Capsules, Takeda Global Research & Development Center, Inc., Labeling Revision
Tretinoin Cream, Triax Pharmaceuticals, LLC, Approval
Vivitrol (naltrexone) Extended-Release Injectable Suspension, Alkermes, Inc., Labeling Revision

March 23, 2010

Amlodipine and Valsartan Tablets, Par Pharmaceutical, Inc., Tentative Approval
Eszopiclone Tablets, Lupin Ltd., Tentative Approval
Gemzar (gemcitabine hydrochloride) Injection, Eli Lilly and Co., Labeling Revision
Memantine Hydrochloride Tablets, Teva Pharmaceuticals, Tentative Approval
Mirapex ER (pramipexole dihydrochloride) Extended-Release Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Approval
Skelid (tiludronate disodium) Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision
Toprol-XL (metoprolol succinate) Extended Release Tablets, AstraZeneca LP, Approval

CDER Meetings

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
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

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM₁₉₇ Protein)
Approval History, Letters, Reviews, and Related Documents, Posted: 3/26/2010
Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth
Posted: 3/26/2010
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
Updated: 3/25/2010
Waivers for Conflicts of Interest for the April 12, 2010 Blood Products Advisory Committee Meeting
Posted: 3/25/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Consumer Safety Technician (OA), OBRR/DBA, Posted: 3/25/2010
Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Updated: 3/24/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary Scientist, OCTGT/DHT, Posted: 3/23/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Support Specialist, OVRR/DVRPA/OM, Posted: 3/23/2010
Update on Rotarix Vaccine
Rotavirus Vaccine, Live, Oral, Posted: 3/22/2010
Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2009
Posted: 3/22/2010

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 26, 2010

March 25, 2010

Federal Register: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop.

March 24, 2010

March 23, 2010

PMA Final Decisions for February

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 - 73
Tuesday - 3

Fri, March 26, 2010

RULES

Listing of Color Additives Exempt From Certification:
     Bismuth Citrate
     14491–14493 [2010–6731]   [TEXT]  [PDF]

PROPOSED RULES
Implementation of Device Registration and Listing Requirements; Public Health Security and Bioterrorism Preparedness and Response Act, etc.
14510–14538 [2010–6662]   [TEXT]  [PDF]

NOTICES

Guidance for Industry:
     Anesthetics for Companion Animals; Availability
     14604 [2010–6700]   [TEXT]  [PDF]
     Drug–Induced Liver Injury: Premarketing Clinical Evaluation; Opening of Comment Period; Public Conference
     14602–14603 [2010–6701]   [TEXT]  [PDF]

Small Entity Compliance Guide:
     Bottled Water: Total Coliform and E. coli; Availability
     14607–14608 [2010–6699]   [TEXT]  [PDF]

Thurs, March 25, 2010

RULES - NONE

NOTICES

Determination:
     DIDREX (Benzphetamine Hydrochloride) Tablets, 25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
     14444–14445 [2010–6593]   [TEXT]  [PDF]

Guidance for Industry:
     Submitting a Report for Multiple Facilities to Reportable Food Electronic Portal, et al.
     14445–14446 [2010–6578]   [TEXT]  [PDF]

Public Workshops:
     FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices
     14448–14449 [2010–6579]   [TEXT]  [PDF]

Wed, March 24, 2010

RULES - NONE

NOTICES

Medical Device Epidemiology Network:
Developing Partnership Between the Center for Devices and Radiological Health and Academia; Public Workshop
14170–14171 [2010–6446] [TEXT] [PDF]

Tue, March 23, 2010

RULES

Product Jurisdiction:
Change of Address and Telephone Number; Technical Amendment
13678 [2010–6246] [TEXT] [PDF]

NOTICES

Draft Guidance for Industry:
     Irritable Bowel Syndrome Clinical Evaluation of Products for Treatment; Availability
     13765–13766 [2010–6310]   [TEXT]  [PDF]

Food and Drug Administration Partnering With Industry; Public Conference:
     Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing
     13766 [2010–6265]   [TEXT]  [PDF]

Guidance for Industry:
     Content and Format of Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
     13766–13767 [2010–6322]   [TEXT]  [PDF]

Mon, March 22, 2010

RULES - NONE

NOTICES

Agency Information Collection Activities; Proposals, Submissions, and Approvals:
     Focus Groups About Drug Products, as Used by the Food and Drug Administration
     13548–13549 [2010–6172]   [TEXT]  [PDF]
     Guidance for Industry Entitled Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims
     13547–13548 [2010–6173]   [TEXT]  [PDF]

Compliance Policy Guide:
     Canned Salmon–Adulteration Involving Decomposition; Withdrawal of Guidance
     13555–13556 [2010–6209]   [TEXT]  [PDF]

Filing of Color Additive Petition:
     Biocompatibles UK Ltd.
     13556 [2010–6177]   [TEXT]  [PDF]

Impact of Dissolvable Tobacco Use on Public Health; Request for Comments
13556–13557 [2010–6216]   [TEXT]  [PDF]

Meetings:
     Endocrinologic and Metabolic Drugs Advisory Committee
     13559–13560 [2010–6169]   [TEXT]  [PDF]

Revised Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Renal Function:
     Study Design, Data Analysis, and Impact on Dosing and Labeling; Availability
     13562–13563 [2010–6171]   [TEXT]  [PDF]

FDA Press Announcement - Back to top

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 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

NEW Handbooks

NEW - US-EU-Japanese GMPs

NEW - GMP Auditor’s Basics

- ICH Guidelines

- GLP Master Guide Handbook

- GCP Clinical Master Reference

- US-EU-Canadian Device handbook

- Canadian GMPs - 2009
- Canadian Medical Device

- Pharmacovigilance Volume 9a

- Food/Supplements GMPs

- Quality Systems Manual

- QSIT Manuals

- EU/US Combo Handbooks

- Electronic Systems Master Handbook

FDA Handbooks

Fax Form

Blood & Cell Industry

Food Handbooks

Dietary Handbooks

Cosmetic Industry

more...

GXP Academy | Conferences | Discussions | FDA.COM Job Board | On-Demand Printing - Custom CRFs

New! - GLP Master Handbook - 2009 Canadian GMPs - Eudralex Pharmacovigilance Volume 9a - Electronic Systems Master Handbook | Fax Form

The e-Newsletter of
What's New with CDER, CDRH & CBER
Distributed by the worlds leader in Federal Regulations,
GMP Publications, Inc. & FDA.COM
Tel: 866-GXPNews (or 856-810-7331) Fax: 856-810-7339
http://www.gmppublications.com / http://www.fda.com John Cuspilich, Sr. Editor, GXPNews
If you would like to advertise in this eNewsletter, call 856-810-1825