In India, Illicit Pharmaceuticals Ravage Communities and Lives
NEW DELHI, India — Dharminder was just 17 years old when his half-naked body was found one morning in an alley near Jahangirpuri station, the northern terminus of the New Delhi Metro’s yellow line. The teen’s body was slung onto a vegetable cart and covered with a blanket that left his bare toes exposed as […]
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More Kids Accidentally Poisoned With Pharmaceutical Products In USA
The number of children who are accidentally poisoned with pharmaceuticals has increased in the USA, despite efforts to improve packaging safeguards, researchers from Cincinnati Children’s Hospital Medical Center and the University of Cincinnati reported in the Journal of Pediatrics. The authors explain that this alarming increase in childhood injuries from pharmaceutical poisoning needs to be […]
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FDA lacks evidence for case against Triad
Federal regulators have found no firm link between contaminated alcohol wipes made by a Wisconsin company and hundreds of reported ailments, from rashes to at least eight deaths, the U.S. Food and Drug Administration said this week. NEW WEBINAR – What You’ve Got to Know About the Incoming Bombshell – FDA’s 2011 Process Validation Guidance […]
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Sun Pharma: Unit Has Resolved Issue Arising From US FDA Warning
Sun Pharmaceutical Industries Ltd. (524715.BY) said Monday one of its U.S. units has successfully resolved an issue arising from a U.S. Food and Drug Administration warning to its manufacturing facility in Cranbury, New Jersey, over regulatory violations. Sun Pharmaceutical Industries Inc.’s facility has been found to have an “acceptable” regulatory status after the FDA re-inspected […]
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Qualitest recalls oral contraceptives
Qualitest Pharmaceuticals is recalling multiple lots of birth-control pills because of a packaging error that could lead to incorrect dosing and unintended pregnancies. NEW WEBINAR – What You’ve Got to Know About the Incoming Bombshell – FDA’s 2011 Process Validation Guidance The company says the error caused the weekly tablet orientation to be reversed and […]
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Who’s To Blame For Lousy Patient Adherence?
This may depend upon who one asks, but a majority of pharmacists apparently believe they have only themselves to blame. At least that is the outcome of new survey, which finds that 76 percent of pharmacists say they have the most responsibility for patient adherence and compliance. Another 16 percent cite physicians, while only 5 […]
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Icahn Strategist Behind Pharma Forays May Leave
A key strategist behind the various forays Carl Icahn has made into pharmaceutical and biotech boardrooms may be leaving the billionaire investor. Alex Denner, a senior managing director at Icahn Enterprise, may start his own hedge fund by the end of the year, although Icahn could wind up becoming one of the investors, Bloomberg News […]
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Genzyme Stumbles Again: New Cerezyme Problems
Serious manufacturing problems are often difficult to resolve, but the Genzyme team appears determined to take the experience to new levels. The beleaguered biotech, which is now both a headache and an opportunity for Sanofi, just sent a letter to Gaucher disease patients to say that supplies of its Cerezyme medicine are being rationed on […]
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FDA Inspects Sabinsa’s Indian Facilities
After inspecting five of Sabinsa’s manufacturing facilities in India, FDA found no issues of concern in four of the facilities, but issued a 483 observation to the herbal intermediates manufacturing facility. The issue involved a polyliner becoming tangled in the conveyer belts leading to the extraction chamber, and Sabinsa reported it corrected the issue and […]
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FDA announces new staff training for medical device reviewers
The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH). Advertisement: New Webinar Oct. 25 – Audit Your Lab Like an FDA Auditor Featuring Carmen Medina […]
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