Update : 1
Subject: Good Clinical Practice Update (April 2008)
The following information was recently added to U.S. Food & Drug Administration (FDA) home page:
2002 (redacted) GCPquestions inquiries and replies
This information is http://www.fda.gov/oc/gcp/redactedEmails/default.htm
Update : 2
Subject: The April 2008 FDA Patient Safety News is now available...
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You can find more information about
Decellularized Allograft Heart Valve Approved
FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed…
Fentanyl (Duragesic) Patches Recalled
Gel leaks from defective patches may cause respiratory depression and death…
New Safety Warnings about Chantix
Possible neuropsychiatric problems and changes in behavior linked to Chantix (varenicline), a smoking-cessation drug…
Early Communication on Adverse Events from Botox and Myobloc
Botulinum toxin may have spread beyond injection site and cause symptoms associated with botulism, including dysphagia and respiratory insufficiency…
New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch
Results of new study found women aged 15-44 who used the patch were at higher risk of developing venous thromboembolism than women using birth control pills…
Remembering to Re-Activate a Patients’s Defibrillator
A recent FDA article in Nursing2008 about a patient who died, possibly of ventricular fibrillation, following elective surgery because his ICD wasn't reactivated…
Mixups between Insulin U-100 and U-500
ISMP describes medication errors could result in dangerous hyper or hypo-glycemia…
Caution Giving Children Cough and Cold Medicines
Ongoing evaluation of cough and cold medicines for children two and older…
For more
Update : 3
Subject: Interstate Certified Shellfish Shippers Update April 2008
* * * Interstate Certified Shellfish Shippers List * * *
The monthly ICSSL update is now available for download at http://www.cfsan.fda.gov/~ear/shellfis.html.
April 2008 Update
Update : 4
Subject: Warning About Total Body Liquid Supplements
Warning About Total Body Liquid Supplements
Tue, 1 Apr 2008 14:47:00 -0500
FDA is advising consumers not to buy or use certain Total Body liquid dietary supplement products because of reports of serious reactions.
Update : 5
Subject: Use Caution with Over-the-Counter Creams, Ointments
Use Caution with Over-the-Counter Creams, Ointments
Tue, 1 Apr 2008 14:47:00 -0500
Follow directions for safe use when using over-the-counter creams and ointments.
Update : 6
Subject: CDER New 4/1/2008
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April 1, 2008
- International Conference on Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon, Rockville, MD, April 4, 2008. Meeting Information
- New and Generic Drug Approvals
- Avodart (dutasteride) Soft Gelatin Capsule, GlaxoSmithKline, Labeling Revision
- ANTHELIOS 40 (avobenzone, ecamsule, octocrylene and titanium dioxide) Cream, Loreal, Approval
- Hydroxyzine Hydrochloride Tablets, Northstar Healthcare, Approval
- Metronidazole in Plastic Container Injection, Claris LifeSciences, Approval
- Xyzal (levocetirizine dihydrochloride) Tablets, UCB Inc., Labeling Revision
- Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Draft)
- Warning Letter: Inspection; West Jefferson Medical Center IRB
Update : 7
Subject: FDA Data Standards Update - Announcement for HL7 SPL WG Electronic Establishment Registration Hands-On Training Session
Greetings,
The FDA Data Standards Council SPL web page was updated on Tuesday, April 1, 2008, to include a hyperlink to a web page announcing the following:
HL7 SPL WG Electronic Establishment Registration Hands-On Training Session
Date: April 9, 2008
Location: Web Conference
http://www.fda.gov/oc/datacouncil/hl7_spl_wg_xform_training_04_09_08.html
Lonnie Smith
Project Manager
Structured Product Labeling Team
FDA Data Standards Council
Update : 8
Subject: FDA MedWatch - The April 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. 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 A[pril 2008 edition include:
Decellularized Allograft Heart Valve Approved
FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed…
Fentanyl (Duragesic) Patches Recalled
Gel leaks from defective patches may cause respiratory depression and death…
New Safety Warnings about Chantix
Possible neuropsychiatric problems and changes in behavior linked to Chantix (varenicline), a smoking-cessation drug…
Early Communication on Adverse Events from Botox and Myobloc
Botulinum toxin may have spread beyond injection site and cause symptoms associated with botulism, including dysphagia and respiratory insufficiency…
New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch
Results of new study found women aged 15-44 who used the patch were at higher risk of developing venous thromboembolism than women using birth control pills…
Remembering to Re-Activate a Patients’s Defibrillator
A recent FDA article in Nursing2008 about a patient who died, possibly of ventricular fibrillation, following elective surgery because his ICD wasn't reactivated…
Mixups between Insulin U-100 and U-500
ISMP describes medication errors could result in dangerous hyper or hypo-glycemia…
Caution Giving Children Cough and Cold Medicines
Ongoing evaluation of cough and cold medicines for children two and older…
For more
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