UpDate : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 07:45:38 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: October 15, 2008 |
The following new items were added to the CDRH web pages on October 14, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Information on Cell Phones (Updated) |  |
UpDate : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 09:24:45 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
UpDate : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 11:01:48 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Vacancy Announcement - Supervisory Medical Officer, DCEPTO/OCTGT
Posted: 10/15/2008
Approval Information: Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra) - Sanofi Pasteur Inc.
Posted: 10/15/2008, Approval Date: 10/7/2008
UpDate : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 17:18:21 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Stylesheet Version 4.0.3 & SPL Terminology Updates
Greetings,
The FDA Data Standards Council's SPL web page was updated Wednesday, October 15, 2008, to include:
- Updated version of the SPL stylesheet (version 4.0.3) http://www.fda.gov/oc/datacouncil/StyleSheet_V4_0_3.zip (see release notes for list of changes)
- Added outdated version (4.0.2) of SPL stylesheet to SPL stylesheet archives http://www.fda.gov/oc/datacouncil/stylesheet_archive.zip
- UNII zip file: (added new UNIIs) http://www.fda.gov/oc/datacouncil/UNIIs.zip
- Terminology lists (XML version): http://www.fda.gov/oc/datacouncil/terminology_lists.zip (Added updated UNII XML file and additional route of administration: occlusive dressing technique and concept code.)
- Replace telephone numbers under Contact Information heading with SPL e-mail address on this web page: http://www.fda.gov/oc/datacouncil/spl.html
Lonnie Smith
Project Manager
FDA Data Standards Council
UpDate : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 15:03:25 -0500 (CDT)
Subject: Enforcement Report for October 15, 2008
Enforcement Report for October 15, 2008
Tue, 14 Oct 2008 12:59:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
UpDate : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 15:03:29 -0500 (CDT)
Subject: FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals
FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals
Wed, 15 Oct 2008 15:00:00 -0500
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs
UpDate : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 15:03:32 -0500 (CDT)
Subject: ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
Wed, 15 Oct 2008 14:19:00 -0500
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.
UpDate : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 17:08:59 -0500 (CDT)
Subject: FDA Information Update for Health Professionals - October 15, 2008
U.S. Food and Drug Administration
Office of Special Health Issues
5600 Fishers Lane, HF-12
Rockville, Maryland 20857
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, product approvals, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY INFORMATION:
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.
PRODUCT APPROVALS:
FDA Licenses for Marketing New Therapy for Rare Genetic Disease (October 10)
The FDA licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. The product, called Cinryze, is licensed for the prevention of HAE attacks, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease.
FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland (October 10)
The FDA approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.
FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A (October 10)
The FDA approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.
FDA Approves Use of Temporary Pump to Assist Heart's Right Side (October 7)
The FDA approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen.
FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration (October 7)
The FDA has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials.
ANNOUNCEMENTS:
FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals (October 15)
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page was developed in accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and contains links to, among other things, the following:
drug labeling, including patient labeling, professional labeling, and patient package inserts
a searchable database of postmarket studies that provide the FDA with additional information about a drug's safety, efficacy, or optimal use
Clinicaltrials.gov, a searchable database of clinical trials
drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts
Visit the new website at http://www.fda.gov/cder/drugSafety.htm.
Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval (October 15)
The FDA has launched a new, improved marketed unapproved drug Web site with a section particularly for health care professionals. The site explains the risks posed by unapproved drugs and gives helpful information on how to protect patients.
The site includes:
Video and audio programs, given by FDA physicians and regulators that can be accessed online or downloaded
Questions and answers, public health advisories, and other documents
Enforcement actions taken by FDA (by drug class and by firms)
Background information about marketed unapproved drugs
FDA's initiative against marketed unapproved drugs
Visit the website at http://www.fda.gov/cder/drug/unapproved_drugs/default.htm
The U.S. Food and Drug Administration announced on October 8 that it supports the voluntary actions by the Consumer Healthcare Products Association members to modify the product labels for consumers of over-the-counter cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.
Preparation for International Conference on Harmonization Meetings in Brussels, Belgium
DATE: October 21, 3:00 p.m.
LOCATION: 5600 Fishers Lane, 3rd Floor, Conf. Rooms D and E, Rockville, MD.
CONTACT: Tammie Jo Bell, Office of the Commissioner, 301-827-0003. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Brussels, Belgium, November 10 to 13, at which discussion of the topics underway and the future of ICH will continue. More Information
Endocrinologic and Metabolic Drugs Advisory Committee
DATE: October 21, 8:00 a.m.
LOCATION: Crowne Plaza Hotel, Washington DC-Silver Spring, 8777 Georgia Ave.,
Silver Spring, MD, (301) 589-0800
CONTACT: Paul Tran, R.Ph., 301-827-7001. On October 21, 2008, the committee will discuss the safety and efficacy of biologic license application (BLA) 125291, MYOZYME (algucosidase alfa) Genzyme Corporation, for the treatment of late onset Pompe disease. More Information
Peripheral and Central Nervous System Drugs Advisory Committee
DATE AND TIME: October 23, 8:00 a.m.
LOCATION: Hilton Washington DC, Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, MD
CONTACT: Diem-Kieu Ngo, 301–827–7001
DATE: October 29, 8:00 a.m.
LOCATION: Hilton The Ballrooms, 1750 Rockville Pike, Rockville, MD.
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827-6793.
The committee will provide advice on types of studies and trial designs needed for an influenza antiviral MedKit for the treatment or prophylaxis of pandemic influenza and discuss publicly the proposed development program that would support an application for such a MedKit. Issues such as the role of personal MedKits, home stockpiling, non-prescription availability of influenza medications, and interfaces of home readiness with public health systems, will be raised in the course of the discussions. More Information
Antiviral Drugs Advisory Committee
DATE: October 30, 9:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring, The Ballrooms, 1750 Rockville Pike, Rockville, MD
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827-6793. The meeting will be open to the public from 8 a.m. to 9 a.m., unless public participation does not last that long. From 9 a.m. to 1 p.m., the meeting will be closed to permit discussion of current and future advances on antiviral drugs which will include the review of trade secret and/or confidential information. More Information
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