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Industry News: Page 269
Regulatory
FDA MedWatch - Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials
Amgen and FDA notified healthcare professionals that certain lots of Epogen and Procrit (Epoetin alfa) vials are being recalled as a precaution, because the vials may contain extremely thin glass flakes (lamellae) that are barely visible.
September 30, 2010
Regulatory
DDL, Medical DevicePackage Testing Firm, Announces their Agreement with CITCH
DDL, a leader in medical device package, product, and material testing, announces a cooperative agreement with Pennsylvania-based CITECH, whereby DDL will be taking on testing that was formerly conducted by CITECH.
September 30, 2010
Regulatory
FDA MedWatch - Tygacil (tigecycline): Label Change - Increased Mortality Risk
FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections.
September 30, 2010
Regulatory
FDA MedWatch - Similac Powder Infant Formulas: Recall
Possibility of the presence of a small common beetle in the product. The FDA has determined that while the formula containing these beetles poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae, could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract.
September 24, 2010
Regulatory
August 2010 Drug Safety Labeling Changes: 24 Medical Product Labels with changes
The MedWatch August 2010 Drug Safety Labeling Changes posting includes 24 products with safety labeling changes to the following sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
September 21, 2010
Regulatory
FDA MedWatch - BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall
Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices.
September 21, 2010
Regulatory
Mobile technology provides valuable anti-counterfeit tool
Biofem Pharmaceuticals in Nigeria begins a trial of mobile technology for authentication of packs of Merck's Glucophage Type II diabetes drug.
September 21, 2010
Regulatory
Perspectives on RFID in pharmaceuticals
RFID is a tool that can benefit pharmaceutical manufacturers from clinical trials through to the commercial supply chain.
September 10, 2010
Regulatory
ISPE Risk-maPP conference attendees to receive new Baseline Guide
Attendees will hear from companies that have implemented Risk-MaPP principals, receive downloadable copy of Guide.
September 8, 2010
Regulatory
HCPC 's Sept. 15 Showcase to focus on healthcare reform's impact on pharmaceutical packaging
Bruce Cohen to deliver keynote address at one-day industry event at Honeywell's corporate headquarters in Morristown, NJ.
August 25, 2010
Regulatory
Label issues present varied challenges
Distribution environment, regulatory and compliance issues, and marketing messages are among the key concerns for manufacturers.
August 24, 2010
Pharmaceuticals
In pharmaceuticals we trust?
Drug recalls, counterfeiting, and diversion are creating distrust in the pharmaceutical sector.
August 23, 2010
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