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Industry News: Page 261
Regulatory
Trafficking prescription drugs: A $1 billion industry?
CNNMoney report indicates doctors, Medicare fraud, 'skittles parties' all contribute to a growing street market for prescription meds.
June 2, 2011
Regulatory
FDA MedWatch - Pentrexyl Forte Natural: Recall - Misleading Packaging
Phoenix Import & Distribution announces recall of Pentrexyl Forte Natural dietary supplement.
May 25, 2011
Regulatory
Code reader
May 24, 2011
Regulatory
April 2011 Drug Safety Labeling Changes: 43 products with 22 changes to BW, Contraindications or Warnings
The MedWatch April 2011 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
May 20, 2011
Adherence/Delivery
Children's medication labeling carries weight with the FDA
Agency panel recommends acetaminophen dosage based on a child's weight, not age.
May 20, 2011
Regulatory
Findings From Largest Industry Assessment of 510(k) Process to be Released on May 24, 2011
What: Investigators from Northwestern University will release a new, in-depth analysis of FDA's 510(k) regulatory pathway--through which more than 90% of medical devices receive clearance--and of industry's practices within it. The study is the most comprehensive survey to date about the 510(k) process.
May 19, 2011
Materials
Do traditional FDA 'silos' discourage combination product development?
There exists both promise and roadblocks for combination drug/medical device/biologic products, which present unique packaging challenges.
May 13, 2011
Nutraceuticals/Dietary
Multi-Mex Distributor Inc. Dietary Supplements: Recall - Product Packaging Mimics OTC Antibiotics
Multi-Mex Distributor Inc. recalls dietary supplements distributed in several states.
May 11, 2011
Regulatory
FDA MedWatch - Boston Scientific Devices Stolen - Risk of Infection
AUDIENCE: Risk Manager, Gastroenterology, Urology
May 4, 2011
Regulatory
FDA MedWatch - Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency
Bristol-Meyers Squibb announces voluntary recall of 1,000-count bottles of Coumadin Crystalline 5 mg tablets.
May 4, 2011
Packaging/Filling
Track-and-trace serialization system
May 3, 2011
Regulatory
Tracking recent trends in FDA's enforcement
Measuring agency activity is challenging, but FDA's device, food, and biologics people are the busiest with recalls.
May 2, 2011
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Sustainable Transport Package Reduces Plastic Use While Maintaining High-level Performance
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