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1,251 Results
Type: News
Section: Industry News > Regulatory
Adherence/Delivery
RFID to play big role at new Disney Cancer Center*
When the Disney Family Cancer Center opens in California this February, doctors hope that patients benefit from the extremely high level of care that is typical of the Disney name.
October 17, 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
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
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
Regulatory
FDA Approves Vaccines for 2009 H1N1 Influenza Virus*
The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus.
September 24, 2009
Regulatory
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection*
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug.
September 24, 2009
Regulatory
Track, trace, and authentication system extends to consumers
Complete Inspection Systems, Inc., has partnered with Digimarc Corp. to create an advanced track, trace, and anti-counterfeiting system.
September 11, 2009
Pharmaceuticals
The clinical supply chain: Strategies for scheduled drugs
Regulatory requirements in the clinical trial scheduled-drug supply chain.
September 2, 2009
Supply Chain
Countering counterfeits on the front line
In this question-and-answer article, Lawrence Friedman, partner with the law firm of Barnes, Richardson & Colburn, offers insights and three key steps to uncover counterfeits entering the U.S.
September 2, 2009
Pharmaceuticals
Keeping ahead of the counterfeiters
Packaging innovations must be validated to keep ahead of counterfeiters in the medical device and pharmaceutical industries.
September 2, 2009
Pharmaceuticals
MSU's medical packaging course offered online
Michigan State University's venerable Medical Packaging course is presented virtually.
September 1, 2009
Nutraceuticals/Dietary
New OTC medication label warnings
The FDA toughens regulation of common OTC medications.
September 1, 2009
Medical Device/Packaging
Will FDA changes influence healthcare packaging?
Dr. Michael Drues offers a perspective on the state of the FDA, the 510(k), and labeling issues.
August 31, 2009
Robotics/Automation
Pharmaceutical industry confronts data, change, culture
The pharmaceutical culture faces growing pains of gaining maturity. For example, one company representative remarks, "We're awash in data, but have no information."
August 14, 2009
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