Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 06:20:48 -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.
Draft Guidance for Industry on Integrated Summary of Effectiveness
Posted: 8/27/2008
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 07:02:32 -0500 (CDT)
Subject: Enforcement Report for September 3, 2008
Enforcement Report for September 3, 2008
Wed, 03 Sep 2008 05:40:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 07:32:11 -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) - Summary Basis for Regulatory Action
Posted: 9/3/2008
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 08:01:56 -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) - Summary Basis for Regulatory Action
Posted: 9/3/2008
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 08:15:40 -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 : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 08:24:56 -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) - Summary Basis for Regulatory Action
Posted: 9/3/2008
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 08:49:42 -0500 (CDT)
Subject: FDA Patient Safety News - September 2008 edition
The September edition of FDA Patient Safety News is now available to watch at http://www.fda.gov/psn. Feel free to check out any of the stories in this edition, plus any stories from previous programs.
The headlines for this month are:
-- Mix-ups between Insulin U-100 and U-500
-- Severe Pain with Osteoporosis Drugs
-- Preventing Meningitis in Children with Cochlear Implants
-- More Patient Deaths from Luer Misconnections
-- Preventing Patient Deaths from Fentanyl Patches
-- What to do about Unretrieved Device Fragments
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 10:03:18 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
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Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
Wed, 03 Sep 2008 09:40:00 -0500
See Web site for additional information on this current drug shortage
Message: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 10:25:30 -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.
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 9/3/2008
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 13:52:48 -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.
Vaccines and Related Biological Products Advisory Committee Meeting
Posted: 9/3/2008, Meeting Date: 9/25/2008
Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 18:11:51 -0500 (CDT)
Subject: CDER New September 2 & 3
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September 3, 2008
- Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals [PDF]
- New and Generic Drug Approvals
- Clotrimazole Topical Cream, Nycomed US Inc., Approval
- Ketotifen Fumarate Ophthalmic Solution, Alcon Inc., Approval
- Ramipril Capsules, Zydus Pharmaceuticals USA Inc., Approval
- Ranitidine (ranitidine hydrochloride) Syrup, Amneal Pharmaceuticals, Approval
- Valtrex (valacyclovir hydrochloride) Tablets, GlaxoSmithKline, Patient Population Altered
- Office of Generic Drugs: August First-Time Generic Drug Approvals
- Paragraph IV Patent Certifications (updated)
- What You Should Know about Prescription Drug Advertisements
September 2, 2008
- New and Generic Drug Approvals
- Dexamethasone Sodium Phosphate Injection, Akorn-Strides, Approval
- NORVIR (ritonavir) Capsules, Abbott Laboratories, Labeling Revision
- NORVIR (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Phosphocol P 32 (Chromic Phosphate and P-32) Injection, Mallinckrodt Inc., Labeling Revision
- Stalevo (levodopa and carbidopa and entacapone) Tablets, Orion Corp., Formulation Revision
- Talwin NX (naloxone hydrochloride and pentaz hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision
Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 3 Sep 2008 15:04:54 -0500 (CDT)
Subject: FDA Information Update for Health Professionals - September 3, 2008
U.S. Food and Drug Administration
Office of Special Health Issues
5600 Fishers Lane, HF-12
Rockville, Maryland 20857
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, product approvals, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY INFORMATION:
Information for Healthcare Professionals on Natalizumab Injection for Intraveneous Use (marketed as Tysabri) (August 25)
FDA ALERT [8/2008]: The FDA has recently received information from the manufacturer about two new cases of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri monotherapy for multiple sclerosis in Europe.
FDA is investigating a report from the SEAS trial (Simvastatin and Ezetimibe in Aortic Stenosis) of a possible association between the use of Vytorin (a combination of simvastatin plus ezetimibe) and a potentially increased incidence of cancer.
PRODUCT APPROVALS:
FDA Clears Test to Help Doctors Manage Heart Transplant Patients (August 27)
The U.S. Food and Drug Administration announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.
FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts (August 22)
The U.S. Food and Drug Administration approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.
For more information on product approvals, please visit Approvals of FDA-Regulated Products.
ANNOUNCEMENTS:
The FDA is recruiting for 1,300 medical and science positions to strengthen the agency's public health mission. The FDA has been granted "direct hire" authority to fill these positions quickly with qualified applicants. For dates and schedules for job fairs, please visit FDA's Nationwide Job Fairs.
UPCOMING MEETINGS:
2008 PDA/FDA Joint Regulatory Conference
DATE: September 8-10, 2008
LOCATION: Renaissance Hotel, 999 9th Street NW, Washington, D.C. 20001
CONTACT: Leslie Edmonds, Coordinator, Programs and Meetings, edmonds@pda.org or (301) 656-5900 ext. 160.
FDA Nanotechnology Public Meeting
DATE: September 8, 2008, 8:30 a.m.
LOCATION: University Systems of Maryland, The Universities at Shady Grove Conference Center, 9630 Gudelsky Drive, Rockville, MD
CONTACT: Email nanotech@fda.hhs.gov or call 301-827-3360.
Reproductive Health Drugs Advisory Committee
DATE: September 9, 2008, 8:00 a.m.
LOCATION: Hilton Washington DC Rockville, Plaza Ballrooms I and II, 1750 Rockville Pike, Rockville, MD
CONTACT: Kalyani Bhatt, 301–827–7001.
Blood Products Advisory Committee
DATE AND TIME: September 10-11, 8:00 a.m.
LOCATION: Hilton Hotel, Washington, DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852
CONTACT: Donald W. Jehn or Pearline K. Muckelvene, 301-827-0314.
For notice of advisory committee meetings posted on earlier Health Professional communications additional information can be found after the meeting has been held. For information such as presentations, transcripts and voting results, please see FDA's Advisory Committee page.
RESOURCES:
The FDA the Week: Andy's Take (August 28, 2008)
Commissioner for Food and Drugs Andrew von Eschenbach discusses weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events. Featured this week is "FDA: Science Now and Science in the Future."
FDA Patient Safety News Video Program (September 2008)
This month's FDA Patient Safety News Video Program for health professional features the following articles:
Preventing Medical Errors
· Mixups between Insulin U-100 and U-500
· More Patient Deaths from Luer Misconnections
· Preventing Patient Deaths from Fentanyl Patches
· What to Do about Unretrieved Device Fragments
Recalls and Safety Alerts
· Severe Pain with Osteoporosis Drugs
· Preventing Meningitis in Children with Cochlear Implants
If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below.
Sincerely,
Janelle Derbis, PharmD
312-596-6516 (Chicago)
Brenda L. Evelyn, SBB(ASCP)
Brenda.evelyn@.fda.hhs.gov
301-827-4460
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