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Industry News: Page 260
Supply Chain
Regulatory information for shipping compliance
June 20, 2011
Regulatory
FDA announces new safety recommendations for high-dose simvastatin
The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.
June 18, 2011
Regulatory
FDA announces rules to change sunscreen labels
Agency announces "significant changes" to sunscreen products and their labels that aim to help consumers buy and use them, and protect from harmful UV rays.
June 16, 2011
Regulatory
FDA MedWatch - May 2011 Monthly Safety Labeling Changes includes 47 products with revisions to Prescribing Information
The MedWatch May 2011 Safety Labeling Changes posting includes 47 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
June 16, 2011
Regulatory
ASTM releases new label standards for anesthesiology and pharmaceutical packaging
Revision to ASTM D4774 aims to add another level of safety in patient care. New WVTR standard also approved.
June 14, 2011
Regulatory
FDA Takes 'First Step' Toward Greater Regulatory Certainty Around Nanotechnology
The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size.
June 14, 2011
Regulatory
Film for clinical trials blister packs
June 14, 2011
Regulatory
FDA gives thumbs-up to redesigned labels for some Merck meds
Agency commends Merck's efforts to reduce pharmacy selection errors. The company's Label Standardization Projects includes revisions for 34 container labels for 16 oral solid-dose drugs.
June 13, 2011
Regulatory
Consumers have role in combating pharmaceutical fraud
Consumers, brand owners, and packaging can help battle factors driving pharmaceutical fraud, says report.
June 10, 2011
Regulatory
FDA MedWatch - Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations
Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor
June 10, 2011
Labeling/Printing
St. Mary's employs pharmacy bar-code labeling system
Aimed at improving patient safety at bedside. St. Mary Medical Center recently announced the implementation of technology from Talyst.
June 8, 2011
Regulatory
FDA MedWatch - Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products
FDA and Aidapak Services notifies healthcare professionals and hospital pharmacies of recall of multiple repackaged drug products.
June 4, 2011
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