Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 05:31:02 -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: April 30, 2008 |
The following new items were added to the CDRH web pages on April 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Brief Summary |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 08:14:41 -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, 30 Apr 2008 09:04:34 -0500 (CDT)
Subject: FDA Embarks on Major Hiring Initiative for its Public Health Mission
FDA Embarks on Major Hiring Initiative for its Public Health Mission
Wed, 30 Apr 2008 08:41:00 -0500
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 09:08:59 -0500 (CDT)
Subject: InVitro Diagnostics Update
You are subscribed to InVitro Diagnostics 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, 30 Apr 2008 09:49:29 -0500 (CDT)
Subject: CDER New 4/28/2008
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April 28, 2008
- Drug Master Files (updated)
- Drug Shortage: Resolved; Lymphazurin 1% injection (isosulfan blue)
- New and Generic Drug Approvals
- Anastrazole Tablets, Watson Labs, Tentative Approval
- Aplenzin (Bupropion Hydrobromide) Extended-release Tablets, Biovail Labs, Approval
- Children's Cetirizine Hydrochloride Allergy Syrup, Ranbaxy Labs, Approval
- Children's Cetirizine Hydrochloride Hives Relief Syrup, Ranbaxy Labs, Approval
- Fiorinal with Codeine (butalbital, aspirin, caffeine and codeine phosphate) Capsules, Watson Labs, Labeling Revision
- Maxitrol (neomycin sulfate, polymyxin B sulfate and dexamethasone) Ophthalmic Suspension, Falcon Pharma, Labeling Revision
- Moxifloxacin Hydrochloride Tablets, Dr. Reddy’s Labs, Tentative Approval
- Nicotine Polacrilex Gum (2 mg), Perrigo R & D, Approval
- Nicotine Polacrilex Gum (4 mg), Perrigo R & D, Approval
- Phentermine Hydrochloride Capsules, KVK-Tech, Approval
- Primidone Tablets, Amneal Pharma, Approval
- Promethazine Hydrochloride Injection, Hikma Farmaceutica, Approval
- Relistor (methylnaltrexone bromide) Subcutaneous Injection, Progenics Pharma, Approval
- Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision
- Singulair (montelukast sodium) Tablets, Merck & Co., Labeling Revision
- Singulair (montelukast sodium) Oral Granules, Merck & Co., Labeling Revision
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 09:53:24 -0500 (CDT)
Subject: CDER New 4/29/2008
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April 29, 2008
- Actavis Totowa LLC recalls all strengths of Digitek (digoxin tablets, USP), a drug used to treat heart failure and abnormal heart rhythms
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- New and Generic Drug Approvals
- Efavirenz Tablets, Matrix Labs, Tentative Approval
- Lamivudine and Zidovudine Tablets, Hetero Drugs, Tentative Approval
- Optiray (Ioversol) Injection, Mallinckrodt, Labeling Revision
- Thioridazine Hydrochloride Tablets, Mylan Pharma, Expiration Date Change
- Zidovudine Tablets, Hetero Drugs, Approval
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 15:48:16 -0500 (CDT)
Subject: Mammography What's New Update
You are subscribed to Mammography What's New for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
"Medical Physicist Actions, Re: Units w/Tungsten Target & Silver or Rhodium Filters"
"Clarification of Testing of Initial Power Drive w/Computer-controlled Compression."
"Testing w/Cushion Pads for FFDM Units?"
"Notification of Software Upgrades Under Alternative Standard #6."
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 17:04:08 -0500 (CDT)
Subject: Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Wed, 30 Apr 2008 15:17:00 -0500
Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.
Update: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 15:39:00 -0500 (CDT)
Subject: The May 2008 MedSun Newsletter is now available...
Medical Product Safety Network
Highlighted articles include:
MedSun reporters and other healthcare facilities can still submit heparin reports to MedSun or MedWatch, and they will be directed to the attention of FDA’s Center for Drug Evaluation and Research (CDER)…
FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
Draft guidelines have been issued by FDA to aid the development, testing and manufacture of coronary drug-eluting stents, and devices used to treat blocked heart arteries…
Preventing Accidents and Injuries in the MRI Suite
This article provides risk reduction strategies and Joint Commission recommendations to reduce MRI accidents, injuries, and deaths…
Alarm Interventions during Medical Telemetry Monitoring: A Failure Mode & Effects Analysis
Healthcare facilities can use the published results of the failure mode and effects analysis to understand telemetry monitoring alarm response processes and as an aid to develop facility-specific risk reduction strategies…
Preventing the Retention of Foreign Objects during Interventional Radiology Procedures
The article provides recommendations and safe practices to help prevent the retention of foreign objects during interventional radiology (IR) procedures. This includes the use of sponge, sharp and instrument counts in IR to prevent the risk of serious patient harm related to the retention of foreign objects in this setting…
Based on the observations of an in-vitro study, researchers concluded that no interference effects occurred in pacemakers exposed to the tested iPod devices…
FDA's Office of In Vitro Diagnostics Has Approved the Following New Devices for Marketing:
Dako TOP2A FISH pharmDx™ Kit is a laboratory test used to help a doctor assess the likely clinical course for certain patients with breast cancer. The test uses fluorescent DNA probes to measure the number of copies of the TOP2A (Topoisomerase 2 alpha) gene on chromosome 17 in breast cancer cells...
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