UpDate: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 07:55:27 -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: September 12, 2008 |
The following new items were added to the CDRH web pages on September 11, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of Comment Period |  |  |
| Summary Information for: COBAS® TaqMan® HBV Test For Use With the High Pure System | | |
| | FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008 (Final Agenda Now Available) | | |
| | Federal Register: General and Plastic Surgery Devices: Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period | | |
| Class I Medical Device Recall: Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) | | |
| | Federal Register: Public Advisory Panels or Committees: Request for Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives | | |
UpDate: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 11:08:04 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- FDA: New Early Safety Systems
The FDA this Week: Andy's Take -- FDA: New Early Safety Systems
Fri, 12 Sep 2008 15:19:00 -0500
The FDA has recently posted on our web site the first of what will be quarterly reports that list certain drugs that are being evaluated by the FDA for potential safety issues.
My take is that making you aware of concerns about adverse outcomes or side effects of drugs is similar to giving you a forecast of an impending weather system: we get clues but then we must follow up with science and tracking data to give us more meaningful information.
UpDate: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 12:04:20 -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.
Approval Information: Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone) - Approval history and related documents
Posted: 9/12/2008
UpDate: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 12:13:56 -0500 (CDT)
Subject: LifePak CR Plus AED Recall - Medical Device Safety
Physio Control, Inc. has recalled the LifePak CR Plus Automated External Defibrillator (AED) because the shock button is covered and is not visible. This leaves the responder unable to provide therapy (shock).
UpDate: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 13:01:01 -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.
Approval Information: Blood Grouping Reagent Anti-Fya (Monoclonal) (Seraclone) - Approval History and Related Documents
Posted: 9/12/2008
Approval Information: Blood Grouping Reagent Anti-S (Monoclonal) (Seraclone) - Approval History and Related Documents
Posted: 9/12/2008
UpDate: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 14:04:22 -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.
Important Notification: Red Cell Collection Kits - Haemonetics Corporation - 9/8/2008
UpDate: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 14:06:41 -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.
Substantially Equivalent 510(k) Device - Pool Results Manager Version 1.0C
Posted: 9/12/2008, Clearance Date: 9/3/2008
Important Notification: Red Cell Collection Kits - Haemonetics Corporation
Posted: 9/12/2008: Notification Date: 9/9/2008
UpDate: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 14:29:37 -0500 (CDT)
Subject: FDA MedWatch -Infant Formula Manufactured in China: Health Information Advisory Due To Reports Of Possible Contamination With Melamine
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FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formula have fulfilled the requirements to sell this product 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. Caregivers should not feed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formula manufactured in the United States. Individuals should contact their health care professional if they have questions regarding their infant's health or if they note changes in their infant's health status.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Health Information Advisory regarding the above issue:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#formulaChina
UpDate: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 15:52:05 -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.
Approval Information: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Merck
Posted: 9/12/2008; Approval Date: 9/12/2008
Approval Information: Immune Globulin Intravenous (Human) (Gamunex) - Talecris Biotherapeutics, Inc.
Posted: 9/12/2008; Approval Date: 9/12/2008
UpDate: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 10:02:57 -0500 (CDT)
Subject: FDA Issues Health Information Advisory on Infant Formula
FDA Issues Health Information Advisory on Infant Formula
Fri, 12 Sep 2008 09:26:00 -0500
In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing 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.
UpDate: 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 16:02:49 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
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Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
Fri, 12 Sep 2008 15:55:00 -0500
Updated letter on this current drug shortage
UpDate: 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 16:02:49 -0500 (CDT)
Subject: FDA Approves Treatment for Rare Neurologic Disease
FDA Approves Treatment for Rare Neurologic Disease
Fri, 12 Sep 2008 15:50:00 -0500
The U.S. Food and Drug Administration today 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.
UpDate: 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 12 Sep 2008 17:04:03 -0500 (CDT)
Subject: FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
Fri, 12 Sep 2008 16:39:00 -0500
The U.S. Food and Drug Administration today 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.
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