GXPnews

Fluorouracil Cream, Taro Pharmaceutical Industries Ltd., Approval
Metrogel (metronidazole) Gel, Galderma Laboratories, Labeling Revision
Trelstar (triptorelin pamoate) Injectable Solution, Watson Laboratories, Inc., Approval
Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Company, LLC., Labeling Revision

March 10, 2010

Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca, Labeling Revision
Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca, Labeling Revision

March 9, 2010

Betaxon (levobetaxolol hydrochloride) Ophthalmic Suspension, Alcon Research, Ltd., Labeling Revision
ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision
ChloraPrep One-Step Frepp (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision
ChloraPrep One-Step with Tint (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision
Copegus (ribavirin) Tablets, Hoffmann-La Roche Inc., Labeling Revision
Inderide-40/25 (hydrochlorothiazide and propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, LLC, Labeling Revision
Inderide-80/25 (hydrochlorothiazide and propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, LLC, Labeling Revision
Nexium (esomeprazole magnesium) Delayed-Released Oral Solution, AstraZeneca, Labeling Revision
Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision
Nexium (esomeprazole magnesium) Delayed-Release Oral Solution, AstraZeneca, Labeling Revision
Nexium IV (esomeprazole sodium) Intravenous Injection, AstraZeneca, Labeling Revision
Tyzeka (telbivudine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Tyzeka (telbivudine) Oral Solution, Novartis Pharmaceuticals Corp., Labeling Revision
Vanos (fluocinonide) Topical Cream, Medicis Pharmaceutical Corp., 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

Market Withdrawal of Chiron RIBA HCV 3.0 SIA
Posted: 3/12/2010
FY 2008 Annual Report: Innovative Technology Advancing Public Health
Posted: 3/11/2010
Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Updated: 3/10/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Project Manager, OVRR/DVRPA/IO, Posted: 3/10/2010
Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Analyst, OM/DPS/PSB, Posted: 3/10/2010

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 11, 2010

March 10, 2010

March 8, 2010

Class I Medical Device Recall: Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs)

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 -
Thursday - 558
Monday - 514

Fri, March 12, 2010

RULES - NONE

NOTICES

Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Food and Drug Administration Transparency Task Force
11893–11894 [2010–5377] [TEXT] [PDF]

Thurs, March 11, 2010

RULES - NONE

New Animal Drugs for Use in Animal Feeds:
Zilpaterol
11451–11452 [2010–5224] [TEXT] [PDF]

NOTICES - NONE

Agency Information Collection Activities; Proposals, Submissions, and Approvals:
     Human Cells, Tissues, and Cellular and Tissue-Based Products, etc.
     11545–11549 [2010–5229]   [TEXT]  [PDF]
     Mammography Quality Standards Act Requirements
     11542–11545 [2010–5230]   [TEXT]  [PDF]

Determinations:
     PRO–BANTHINE (Propantheline Bromide) Tablets and 14 Other Drug Products Not Withdrawn, etc.
     11549–11551 [2010–5275]   [TEXT]  [PDF]

Meetings:
     Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
     11551 [2010–5264]   [TEXT]  [PDF]

Wed, March 10, 2010

RULES - NONE

NOTICES

Public Hearing; Request for Comments:
Expanded Access to Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C Infection in Patients With Unmet Medical Need
11189–11191 [2010–5055] [TEXT] [PDF]

Tue, March 09, 2010

RULES - NONE

NOTICES

Determination:
     DOVONEX (Calcipotriene) Ointment, 0.005%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
     10805–10806 [2010–4925]   [TEXT]  [PDF]

Information Available to Industry:
     Training Program for Regulatory Project Managers
     10806–10807 [2010–4924]   [TEXT]  [PDF]

Withdrawal of Color Additive Petitions:
     CIBA Vision Corp.
     10808–10809 [2010–4972]   [TEXT]  [PDF]

Mon, March 08, 2010

RULES

Confirmation of Effective Date:
New Animal Drug Applications
10413 [2010–4923] [TEXT] [PDF]

NOTICES

Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability:
     International Conference on Harmonisation
     10487–10488 [2010–4841]   [TEXT]  [PDF]

Meetings:
     Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
     10488–10489 [2010–4812]   [TEXT]  [PDF]
     Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
     10490 [2010–4813]   [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

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

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March 11, 2010

March 10, 2010

March 8, 2010

FDA Press Announcement - Back to top