Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 08:36:40 -0500 (CDT)
Subject: CDRH New Update
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 | Date: September 17, 2008 |
The following new items were added to the CDRH web pages on September 16, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers |  |  |
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 08:57:18 -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 - Pharmacologist, OD/DVRPA/OVRR
Posted: 9/17/2008
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 09:13:10 -0500 (CDT)
Subject: CDER New 9/16/2008
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September 16, 2008
- FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. Drug Information.
- Meetings of the Nonprescription Drugs Advisory Committee (NDAC) (updated)
- New and Generic Drug Approvals
- Hydralazine Hydrochloride Tablets, Hetero Drugs, Ltd., Approval
- Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Approval
- Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories, Ltd., Tentative Approval
- Remodulin (treprostinil sodium) Subcutaneous I.V. Injection, United Therapeutics Corp., Labeling Revision
- Sancuso (granisetron) Transdermal System, Strakan International, Ltd., Approval
- Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., Labeling Revision
- Rulemaking History for OTC Sunscreen Drug Products: Time and Extent Applications (updated)
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 12:01:51 -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 : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 14:07:24 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies (PDF - 185 KB) - 9/17/2008
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 14:18:33 -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.
International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies
Posted: 9/17/2008
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 9/17/2008
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 15:03:53 -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.
International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies
Posted: 9/17/2008
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 17:17:51 -0500 (CDT)
Subject: CDER New 9/17/2008
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September 17, 2008
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry: S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals [PDF]
- New and Generic Drug Approvals
- Galantamine Hydrobromide Extended-Release Capsules, Barr Laboratories, Inc., Approval
- Lybrel (levonorgestrel and ethinyl estradiol) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Risperidone Tablets, Apotex Corp., Approval
- Risperidone Tablets, Mylan Pharmaceuticals, Inc., Approval
Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 06:02:40 -0500 (CDT)
Subject: Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16)
Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16)
Wed, 17 Sep 2008 05:05:00 -0500
Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product.
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 17 Sep 2008 15:14:46 -0500 (CDT)
Subject: FDA Information Update for Health Professionals - September 17, 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:
FDA Issues Health Information Advisory on Infant Formula (September 12)
In response to reports of contaminated milk-based infant formula manufactured in China, the FDA issued a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.
Rituxan (rituximab) (September 11)
Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study.
FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections (September 4)
FDA announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.
PRODUCT APPROVALS:
FDA Approves Treatment for Rare Neurologic Disease (September 12)
FDA announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers (September 12)
FDA announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.
FDA Approves DNA Test to Measure Hepatitis B Virus Levels (September 4)
FDA approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.
FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures (September 4)
FDA announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.
For more information on product approvals, please visit Approvals of FDA-Regulated Products.
ANNOUNCEMENTS:
FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India (September 16)
FDA issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.
· A replay of the September 16th media teleconference will be available through September 23, 2008. To hear the replay, callers in the US can dial 800-876-5573; international callers can dial 402-220-5329.
FDA to Post Quarterly Report of Potential Safety Issues (September 4)
FDA announced that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).
Vaccines and Related Biological Products Advisory Committee
DATE AND TIME: September 25, 8:30 a.m.
LOCATION: Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910
CONTACT: Christine Walsh or Denise Royster, 301–827–0314.
FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance
DATE AND TIME: October 2-3, 2008
LOCATION: Hilton Wash. DC North/ Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD 20877
CONTACT: Megan Moynahan, 240-276-8707.
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
For notice of advisory committee meetings posted on earlier Health Professional communications additional information can be found after the meeting has been held. For information such as presentations, transcripts and voting results, please see FDA's Advisory Committee page.
RESOURCES:
What You Should Know about Prescription Drug Advertisements
Prescription drug advertisements can provide useful information for consumers to work with their health care providers to make wise decisions about treatment. The example ads provided show the correct and incorrect versions of different types of drug ads.
Please visit Advertising Prescription Drugs and Medical Devices for additional information.
The FDA the Week: Andy's Take (September 12, 2008)
Commissioner for Food and Drugs Andrew von Eschenbach discusses weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events. Featured this week is "FDA: New Early Safety Systems."
If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below.
Sincerely,
Janelle Derbis, PharmD
312-596-6516 (Chicago)
Brenda Evelyn, SBB (ASCP)
301-827-4460
Heidi Marchand, PharmD
301-827-4460
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
