Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Aug 2008 02:06:47 -0500 (CDT)
Subject: CDER New 8/28/2008
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August 28, 2008
- New and Generic Drug Approvals
- Estring (estradiol) Extended-Release Vaginal Insert, Pharmacia & Upjohn Co., Labeling Revision
- Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Manufacturing Change or Addition
- Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB, Inc., Labeling Revision
- NovoLog Mix 50/50 (insulin aspart protamine and insulin aspart) Injectable Suspension, Novo Nordisk, Inc., Approval
- Radiogardase (Prussian Blue) (ferric hexacyanoferrate(II)) Capsules, Heyl Chemisch-Pharmazeutische Fabrik GmbH & Co., Package Change
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Aug 2008 07:49:10 -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: August 29, 2008 |
The following new items were added to the CDRH web pages on August 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications |  |  |
| Class I Medical Device Recall: Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank | |
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Aug 2008 09:32:30 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) FDA this Week: Andy's Take (Podcast alert) Update
You are subscribed to FDA this Week: Andy's Take (Podcast alert) 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: Fri, 29 Aug 2008 10:31:13 -0500 (CDT)
Subject: The September 2008 MedSun Newsletter is now available...
Medical Product Safety Network
Highlighted articles include:
FDA Approves New Genetic Test for Patients with Breast Cancer
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab)...
Implantable Cardiac Defibrillator Lead Failure or Mypotential Oversensing? An Approach to the Diagnosis of Noise on Lead Electrogram
The extraneous noise of an electrogram (EGMs) may lead to inappropriate shocks or inhibition of pacing...
Hypersensitivity Reactions Associated with Endovascular Devices
Hypersensitivity reactions to the biomaterials used in endovascular prostheses are among the infrequent reactions that may lead to local or systemic complications following cardiovascular therapeutic interventions...
The Joint Commission Announces 2009 National Patient Safety Goals for Home Care Program
The Joint Commission has announced the 2009 National Patient Safety Goals and related requirements for accredited home care organizations. The National Patient Safety Goals promote specific improvements in patient safety by providing health care organizations with proven solutions to persistent patient safety problems...
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Aug 2008 12:18:39 -0500 (CDT)
Subject: Good Clinical Practice Update (August 2008)
You may be interested to learn that FDA recently published a draft guidance that contains suggestions about how to successfully complete the Form FDA-1572 (Statement of Investigator). You can find this draft guidance on the Good Clinical Practice Program's home page in the "In the News" section (www.fda.gov/oc/gcp). Alternatively, you can assess this draft guidance directly by linking to the following web address:
http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0406-gdl.pdf
The agency is seeking comments on this draft guidance. You must submit comments by September 29, 2008. Instructions for submitting comments can be found in the Federal Register announcement that is available electronically by linking to the following web address:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17305.htm
If you have any questions, please feel free to contact me directly.
Patricia M. Beers Block
patricia.beersblock@fda.hhs.gov
301-827-6473
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Aug 2008 14:48:29 -0500 (CDT)
Subject: The September 2008 FDA Patient Safety News is now available...
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In this Special Edition of FDA Patient Safety News, we are repeating some of the most important safety issues that continue to pose a public health problem. The month and year that the story first aired is in parentheses at the end of the story headline. You can find more information about the show, read the complete stories and watch or download the program on our web site (http://www.fda.gov/psn):
Mixups between Insulin U-100 and U-500 (April 2008)
ISMP describes medication errors could result in dangerous hyperglycemia or hypoglycemia…
Severe Pain with Osteoporosis Drugs (March 2008)
Incapacitating musculoskeletal pain can occur in patients taking certain bisphosphonate drugs such as Fosamax, Actonel, Reclast and Boniva...
Preventing Meningitis in Children with Cochlear Implants (December 2007)
FDA reminds healthcare professionals and parents about the importance of following immunization recommendations for children with cochlear implants…
More Patient Deaths from Luer Misconnections (October 2007)
Design of luer connectors makes it easy for unrelated delivery systems to be connected to each other, sometimes with disastrous results…
Preventing Patient Deaths from Fentanyl Patches (September 2007)
Patches should only be prescribed for patients who are opioid-tolerant, not those with post-operative or acute pain…
What to Do about Unretrieved Device Fragments (January 2008)
The fragments may have been left in the body because they could not be retrieved or because the risk of removing them was greater than the risk of leaving them in place…
For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Aug 2008 15:18:19 -0500 (CDT)
Subject: CDER New 8/29/2008
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August 29, 2008
- Cyber Letters (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Natural Disaster Response (updated)
- New and Generic Drug Approvals
- Galantamine Hydrobromide Tablets, Alphapharm Party, Ltd., Approval
- Galantamine Hydrobromide Tablets, Barr Laboratories, Inc., Approval
- Glucophage (metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Glucophage XR (metformin hydrochloride) Extended-Release Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Sandostatin (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
- Zemuron (rocuronium bromide) Injection, Organon USA, Inc., Patient Population Altered
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Aug 2008 16:02:34 -0500 (CDT)
Subject: QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28)
QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28)
Fri, 29 Aug 2008 15:34:00 -0500
Quality Food Centers (QFC) said today it is recalling five deli tuna salad items sold at some QFC stores in Washington and Oregon.
Message: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Aug 2008 16:03:36 -0500 (CDT)
Subject: Fresh from the Deli American Sub Sandwich Recalled by Landshire, Inc. Because of Possible Health Risk (August 28)
Fresh from the Deli American Sub Sandwich Recalled by Landshire, Inc. Because of Possible Health Risk (August 28)
Fri, 29 Aug 2008 15:55:00 -0500
Landshire, Inc. is recalling its American Sub sandwich because it has the potential to be contaminated with Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Update: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 30 Aug 2008 23:02:47 -0500 (CDT)
Subject: Trans Ocean Products Recalls Cracked Pepper Style Smoked Salmon LOT No 54933-2 Because of Possible Health Risks (August 29)
Trans Ocean Products Recalls Cracked Pepper Style Smoked Salmon LOT No 54933-2 Because of Possible Health Risks (August 29)
Sat, 30 Aug 2008 19:59:00 -0500
Trans-Ocean Products, Inc. of Bellingham, Washington is recalling its 4 ounce Cracked Pepper Style Smoked Salmon Lot No 54933-2 because it has the potential to be contaminated with Listeria monocytogenes, an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Update: 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 30 Aug 2008 07:08:05 -0500 (CDT)
Subject: FDA MedWatch - The September 2008 FDA Patient Safety News is now available....
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FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. This special edition repeats some of the most important safety issues that continue to pose a public health problem. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the September 2008 edition include:
Mixups between Insulin U-100 and U-500 (April 2008)
ISMP describes medication errors could result in dangerous hyperglycemia or hypoglycemia…
Severe Pain with Osteoporosis Drugs (March 2008)
Incapacitating musculoskeletal pain can occur in patients taking certain bisphosphonate drugs such as Fosamax, Actonel, Reclast and Boniva...
Preventing Meningitis in Children with Cochlear Implants (December 2007)
FDA reminds healthcare professionals and parents about the importance of following immunization recommendations for children with cochlear implants…
More Patient Deaths from Luer Misconnections (October 2007)
Design of luer connectors makes it easy for unrelated delivery systems to be connected to each other, sometimes with disastrous results…
Preventing Patient Deaths from Fentanyl Patches (September 2007)
Patches should only be prescribed for patients who are opioid-tolerant, not those with post-operative or acute pain…
What to Do about Unretrieved Device Fragments (January 2008)
The fragments may have been left in the body because they could not be retrieved or because the risk of removing them was greater than the risk of leaving them in place…
For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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