Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 8 Sep 2008 08:33:58 -0500 (CDT)
Subject: CDER New September 5
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September 5, 2008
- Adverse Event Reporting System (AERS) (updated)
- FDA posts quarterly report of potential safety issues. FDA News
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- New and Generic Drug Approvals
- Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Labeling Revision
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
- Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
- Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS): January - March 2008
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 8 Sep 2008 10:05:25 -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.
Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases
Posted: 9/8/2008
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 8 Sep 2008 10:07:25 -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.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 8 Sep 2008 13:02:54 -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.
FEDERAL REGISTER: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, Final Rule
Posted: 9/8/2008
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 8 Sep 2008 13:04:59 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update
You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 8 Sep 2008 14:41:30 -0500 (CDT)
Subject: MedWatch - Disposable Battery Operated Lavage System: risk of explosion and harm to patients and staff
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Disposable Battery Operated Lavage System (BOLS)
Audience: Operating room, outpatient and emergency room supervisory staff and physicians, risk managers
FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems' (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursing units. The cutting of the battery pack's cable can lead to a short circuit, causing the batteries to discharge rapidly, producing intense heat and flammable gases with a resulting explosion that expels flammable gases and toxic chemicals endangering both patients and staff. Recommendations for avoiding this risk are provided in the medical device safety alert.
Read the complete MedWatch 2008 Safety summary, including a link to the Medical Device Safety alert, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#BOLS
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