Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 06:50:23 -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.
Untitled Letter: Antithrombin III, Human (Thrombate III), Talecris Biotherapies, Inc.
Posted: 10/7/2008
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 06:55:57 -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 - Consumer Safety Officer, DRB/DBA/OBRR
Posted: 10/7/2008
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 07:44:03 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: October 7, 2008 |
The following new items were added to the CDRH web pages on October 6, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | CDRH Learn |  |
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 08:34:39 -0500 (CDT)
Subject: CDER New
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October 6, 2008
- Emergency Use Authorization (EUA) for the Pre-Event Provision and Potential Use of Doxycycline Hyclate Tablet Emergency Kits for Inhalational Anthrax
- Inactive Ingredient Database (updated)
- Bromocriptine Mesylate Tablets, Paddock Laboratories, Inc., Approval
- Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Galantamine Hydrobromide Extended-release Capsules , Barr Laboratories, Inc., Approval
- Hylenex[rDNA origin] (hyaluronidase [rDNA origin]) Injection, Halozyme Therapeutics Inc., Labeling Revision
- Nitrolingual (nitroglycerin) Spray, Sciele Pharma, Inc., Package Change
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 11:42:49 -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.
Draft Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Product (PDF - 125 KB)
Posted: 10/7/2008; Issued: 9/30/2008
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 12:09:30 -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.
PDUFA Pilot Project Proprietary Name Review; Concept Paper (PDF -295 KB)
Posted: 10/7/2008; Issued: 9/30/2008
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 12:35:15 -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 - Mathematical Statistician, OBE
Posted: 10/7/2008
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 14:07:06 -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.
Medical Device Notification (PSN-08-09) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc.
Posted: 10/7/2008, Recall Date: 9/30/2008
Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 14:08:22 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 15:33:58 -0500 (CDT)
Subject: CDER New 10/7/2008
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October 7, 2008
- FDA issues an updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler). Information
- Guidance for Industry: PDUFA Pilot Project: Proprietary Name Review (finalized) [PDF]
- New and Generic Drug Approvals
- Arsenic Trioxide Injection, Teva Parenteral Medicines, Inc., Tentative Approval
- Cipro (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro In Dextrose 5% in Plastic Container (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro XR (ciprofloxacin and ciprofloxacin hydrochloride) Extended-Release Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Flo-Pred (prednisolone acetate) Oral Suspension, Taro Pharmaceuticals, USA, Inc., Package Change
- Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Primidone Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Relenza (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 11:05:41 -0500 (CDT)
Subject: FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration
FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration
Tue, 07 Oct 2008 10:24:00 -0500
The U.S. Food and Drug Administration 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.
Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 7 Oct 2008 13:02:46 -0500 (CDT)
Subject: FDA Approves Use of Temporary Pump to Assist Heart's Right Side
FDA Approves Use of Temporary Pump to Assist Heart's Right Side
Tue, 07 Oct 2008 12:48:00 -0500
The U.S. Food and Drug Administration 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. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. 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.
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