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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FDA says industry must take responsibility for supply chain security
The US Food and Drug Administration has called on lawmakers to grant the agency more regulatory powers so that it can place the onus on industry to tighten pharmaceutical supply chain security. In testimony before the Senate Committee on Health, Education, Labor and Pensions (HELP), FDA Deputy Commissioner for Global Regulatory Operations and Policy Deborah […]
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Michele Bachmann And The HPV Vaccine Bounty
Now that the Minnesota congresswoman and Republican presidential candidate Michele Bachmann has contended that the Merck Gardasil vaccine for combating HPV may have been responsible for mental retardation, she is encountering some pushback. This is not surprising, given that such comments feed into the ongoing controversy over vaccine safety, in general. To date, there is […]
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FDA, Compounded Animal Drugs & Overreaching
Should the FDA have the authority to stop pharmacies from using bulk ingredients to compound prescription meds for non-food producing animals, such as dogs and horses? In an interesting case, a federal court judge has ruled the agency does not have this authority but, moreover, attempted to overstep its bounds in a potentially draconian way […]
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Pfizer Cuts Jobs In Germany: Is It Payback?
There is certainly nothing surprising that Pfizer or any other large drugmaker is planning to cut jobs. A few hundred here. A few thousand there. The drumbeat is been sounding for a few years now. And so a story that Pfizer is eliminating about 500 positions in Germany, at first blush, may not generate much […]
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