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Industry News: Page 281
Regulatory
October 2009 FDA Patient Safety News now available*
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients.
October 15, 2009
Regulatory
Neuron 6F 070 Delivery Catheter*
Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter.
October 14, 2009
Regulatory
New USP Standards for Heparin Products Will Result in Decreased Potency*
Adjustments may be needed to achieve desired anticoagulant effect in some patients New Heparin to Ship Starting October 8
October 14, 2009
Regulatory
Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors*
FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension.
October 13, 2009
Regulatory
When packaging and labeling help fight drug counterfeits
In the U.S. Food and Drug Administration's ongoing battle against counterfeit drug products, the latest FDA guidance is aimed directly at packaging techniques.
October 10, 2009
Regulatory
FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies*
The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.
October 9, 2009
Regulatory
Nationwide Voluntary Product Recall of Neocate Infant Specialized Formula Lot P91877*
Nutricia North America, Inc. ("Nutricia") has contacted customers to undertake the voluntary recall and replacement of one (1) lot of the specialized infant formula product, Neocate.
October 9, 2009
Regulatory
Children's and Infants' Tylenol Oral Suspension Products - Recall*
McNeil Consumer Healthcare and FDA notified consumers of a nationwide recall of certain Tylenol products as a precautionary measure because of potential manufacturing problems.
October 9, 2009
Pharmaceuticals
Fraudulent marketing - caught in the act*
In the wake of Pfizer's massive $2.3 billion settlement in the US for fraudulent marketing, Informa's The Regulatory Affairs Journal - Devices provides comprehensive, step-by-step recommendations on how companies that make medical devices or pharmaceuticals can avoid prosecution and protect their individual employees too.
October 9, 2009
Traceability/Serialization
Serialization for pharmaceutical and medical device--a global strategy
Joe Ringwood, COO of Systech, told a Pack Expo audience yesterday that a serialization strategy must protect data integrity and security, without compromising throughput.
October 7, 2009
Materials
Accusure Insulin Syringes: Nationwide recall - found to have needles which can detach from the syringe*
Qualitest Pharmaceuticals, Inc., today has issued a voluntary nationwide recall of Accusure Insulin Syringes (1/2 cc - 31 G - Short Needle) with lot number 6JCB1 (Expiration 10/2011) - NDC 0603-7001-21.
October 2, 2009
Regulatory
35 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions*
The MedWatch August 2009 Drug Safety Labeling Changes posting includes 35 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
September 25, 2009
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