Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 06:00:46 -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: June 23, 2008 |
The following new items were added to the CDRH web pages on June 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Office of Device Evaluation (ODE) Fiscal Year 2006 and Fiscal Year 2007 Annual Report |  |  |
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 16:02:54 -0500 (CDT)
Subject: How to Dispose of Unused Medicines
How to Dispose of Unused Medicines
Mon, 23 Jun 2008 15:43:00 -0500
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them.
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 16:03:07 -0500 (CDT)
Subject: Radiology and Children: Extra Care Required
Radiology and Children: Extra Care Required
Mon, 23 Jun 2008 15:43:00 -0500
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children.
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 16:03:14 -0500 (CDT)
Subject: Stay Healthy While Traveling Abroad
Stay Healthy While Traveling Abroad
Mon, 23 Jun 2008 15:43:00 -0500
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad.
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 16:03:22 -0500 (CDT)
Subject: Pet Food Products Seized at PETCO Distribution Center
Pet Food Products Seized at PETCO Distribution Center
Mon, 23 Jun 2008 15:43:00 -0500
Consumers who bought animal food products from PETCO in 16 states should take certain precautions
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 16:10:21 -0500 (CDT)
Subject: FDA News Digest
FDA News Digest
June 23, 2008
_____________________________________
IN THIS WEEK'S ISSUE
» News
-- U.S. Marshals Seize Animal Food Products Stored at
» Consumer Health Information FDA has approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Spinal cord injuries can cause paralysis, which can affect the muscles of the chest and abdomen, including the diaphragm—the lower abdominal muscle essential for breathing. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01853.html U.S. Marshals Seize Animal Food Products Stored at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01854.html
To access the RSS feed of FDA news releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
_____________________________________________
SAFETY ALERTS/RECALLS
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
UPCOMING PUBLIC MEETINGS
For a complete list of upcoming meetings, seminars, and other public events sponsored
or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.
Consumer updates in the spotlight this week are:
http://www.fda.gov/consumer/updates/cancerfraud061708.html
http://www.fda.gov/consumer/updates/regranexcream061108.html
For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 17:03:36 -0500 (CDT)
Subject: Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Mon, 23 Jun 2008 16:23:00 -0500
Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 12:37:28 -0500 (CDT)
Subject: FDA MedWatch - February 2008 Drug Safety Labeling Changes for 47 drugs now available on web
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The February 2008 posting includes 47 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/SAFETY/2008/feb08_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/feb08.htm
In February 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets
Cleocin Sterile Solution (clindamycin injection)
Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution
Duragesic (fentanyl) Transdermal System
Emsam (selegiline transdermal system) Patches
Fentora (fentanyl buccal tablet)
Lincocin (lincomycin) Injection
Asmanex Twisthaler (mometasone furoate inhalation powder)
Abilify (aripiprazole) Tablets and Oral Solution
Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets
Abilify (aripiprazole) Injection for Intramuscular Use Only
Avastin (bevacizumab) for Intravenous Use
Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP)
Cortenema (hydrocortisone retention enema)
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets
Eryc (erythromycin delayed-release capsules, USP)
Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution
Geocillin (carbenicillin indanyl sodium) Tablets
Halcion (triazolam tablets)
Janumet (sitagliptin/metformin HCl) Tablets
Letairis (ambrisentan) Tablets
Premarin Intravenous (conjugated estrogens, USP) for injection
Remodulin (treprostinil sodium) Injection
Restoril (temazepam) Capsules
Reyataz (atazanavir sulfate) Capsules
Sensipar (cinacalcet) Tablets
Ultram ER (tramadol HCl) Extended-Release Tablets
Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup
Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension
Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets
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