U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 27 Mar 2008 09:20:21 -0500 (CDT)
Subject: Drug Information Update- Risk Evaluation and Mitigation Strategy (REMS)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS.

There was a Federal Register published March 26, 2008, entitled Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies (REMS) for Purposes of the Food and Drug Administration Amendments Act of 2007. You can access this document at :

http://www.regulations.gov/fdmspublic/ContentViewer?bjectId=090000648040b1f8&disposition=attachment&contentType=html

For further information, please view the questions and answers at:

http://www.fda.gov/cder/regulatory/FDAAA/FR_QA.htm

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http://drugspedia.net/

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 24 Mar 2008 14:07:08 -0500 (CDT)
Subject: Oncology Drugs Update: FDA Approves Bendamustine Hydochloride (Treanda)

FDA Approves Bendamustine Hydochloride (Treanda) for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL).  More information at:

http://www.fda.gov/cder/Offices/OODP/whatsnew/bendamustine.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 13 Mar 2008 11:14:46 -0500 (CDT)
Subject: Oncology Drugs Update: New Approval for Bevacizumab (Avastin)

On February 22, 2008, the U.S. Food and Drug Administration granted accelerated approval for bevacizumab (Avastin, Genentech, Inc.) to be used in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer.  More information at http://www.fda.gov/cder/Offices/OODP/whatsnew/bevacizumab200802.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 4 Mar 2008 09:38:09 -0600 (CST)
Subject: Drug Information Update- Generic Drugs

 

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

Each year, FDA approves scores of generic drugs that treat a variety of conditions and help consumers save money.

Generic drugs cost about 20% to 70% less than their brand name counterparts. The Congressional Budget Office has reported that generic drugs save consumers an estimated $8 billion to $10 billion a year.

 

Generic drugs are identical to their brand-name equivalents in dosage, safety, strength, quality, performance characteristics, intended use, and the way they're administered to patients.

 

For more information on generic drugs and recent approvals go to http://www.fda.gov/consumer/updates/genericdrugs030308.html

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Feb 2008 08:46:56 -0600 (CST)
Subject: Drug Information Update

 

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

FDA is issuing this public health advisory to highlight the correct use of Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) capsules.  Spiriva and Foradil capsules are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease (COPD) and bronchitis. The medication in the Spiriva or Foradil capsules is specifically designed to be inhaled through inhalation devices. Both Spiriva and Foradil will not treat a patient’s breathing condition if the contents of a capsule are swallowed rather than inhaled.

For more information, please visit: http://www.fda.gov/cder/drug/advisory/tiopropium_formoterol.htm 

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Feb 2008 11:43:17 -0600 (CST)
Subject: The March 2008 MedSun Newsletter is now available...

Highlighted articles include:

 

CT Scans May Affect Implantable Electronic Devices

Reports of individuals with implantable electronic devices being shocked while passing through anti-theft systems and airport security…

 

Smart Infusion Pump Technology: Don't Bypass the Safety Catches

These pumps can reduce the risk of administering IV medications, unfortunately, errors may still occur.

 

National Patient Safety Awareness Week March 2 - March 8, 2008

National Patient Safety Awareness Week is an educational and awareness-building campaign for improving patient safety at the local level…

 

Medical Product Safety Network

You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).

The content on the Homepage has been updated to reflect this month's Newsletter items.  This information can be viewed by clicking here

 

 

 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420