Update : 1
Subject: FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
Wed, 26 Mar 2008 11:55:00 -0500
U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach today announced that the agency has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.
Update : 2
Subject: Tropifresh, Inc. Recalls Whole Cantaloupe Products Because of Possible Health Risk (March 26)
Tropifresh, Inc. Recalls Whole Cantaloupe Products Because of Possible Health Risk (March 26)
Wed, 26 Mar 2008 15:33:00 -0500
Tropifresh, Inc. of Los Angeles, CA is recalling Agrolibano’s Produce Brand whole Cantaloupes because they appear to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Update: 3
Subject: Enforcement Report for March 26, 2008
Enforcement Report for March 26, 2008
Wed, 26 Mar 2008 16:41:00 -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 : 4
Subject: CDER New 3/26/2008
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March 26, 2008
- Drugs@FDA Downloadable Data Files (updated)
- FDA releases information on Risk Evaluation and Mitigation Strategies (REMS).
- Guidance for Industry: Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies [PDF]
- New and Generic Drug Approvals
- AMRIX (cyclobenzaprine hydrochloride) Extended-Release Capsules, Anesta AG, Labeling Revision
- Depakote (divalproex sodium) Sprinkle Capsules, Abbott Labs, Patient Population Altered
- Depakote ER (divalproex sodium) Extended-Release Tablets, Abbott Labs, Patient Population Altered
- INVANZ (ertapenem sodium) Injection, Merck & Co., Labeling Revision
- Tigan (trimethobenzamide hydrochloride) Capsules, King Pharma, Labeling Revision
- Warning Letters
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