FDA/Customs Country of Origin Confusion on Drug Imports
Learn About PREDICT – FDA’s New Import Screening Program April 1, 2013 When drugs are imported into the US, there is a lot of information that needs to be reported to US Customs and to FDA. The information is collected and transmitted by computer, usually done by the importing company’s designated broker. One of the […]
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Autism Not Caused by Vaccines: Study
For years, countless parents have blamed the childhood vaccination schedule – and sometimes, specific vaccines – as a risk for developing autism. In fact, about one-third of parents continue to express concern about the cumulative effect of the number of vaccines (click here for a back story). And nearly one in 10 parents refuse or delay […]
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CRO Employee Turnover Rate Spikes
As the contract research organization readies for a rebound this year, many CROs may find their trusted employees are getting ready to walk out the door. These companies are experiencing “dramatically†higher turnover rates compared with other industries, thanks to a hot job market in the CRO sector, according to a new survey. Quality Agreement […]
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Alexion Hammered in FDA Inspection
One of the darlings of the biotech industry has suffered a blow following an FDA inspection of its Rhode Island facility. Alexion Pharmaceuticals disclosed this morning that the agency issued a so-called 483 inspection report, which refers to a failure to adhere to various good manufacturing practices. This plant is where Alexion manufactures Soliris, an orphan drug […]
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J&J recalls nearly 2 million blood glucose meters worldwide
May 7 – FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy Johnson & Johnson is recalling and replacing nearly 2 million meters used to measure blood glucose levels in diabetics due to a failure to operate properly at extremely high glucose readings, the company’s LifeScan unit said on Monday. In […]
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Recalled Drugs from MA Compounding Pharmacy Shipped to 21 States
A recall by a Woburn MA compounding pharmacy where inspectors found visible contaminants in drug vials is more expansive than originally reported by the company on Monday, applying to 25 products distributed to patients and doctors in 21 states, including all New England states. A Pallimed Solutions spokesman told Travis Andersen of the Globe staff […]
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Desperate CEOs Fight to Boost Diabetes Business
7 Tips to Hire Top GMP Consultant Eager to boost its diabetes business, Novo Nordisk has been quick to hire spokespeople to tout its products and franchises. Last year, this strategy bruised its image, though, when the drugmaker secured Paula Dean, the self-professed Queen of Southern Cuisine (click here). And recently, Novo pilfered professional cyclist […]
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FDA Gives Thumbs Up to Biogen Multiple Sclerosis Pill
April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 11 – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, And 21 Tips and Tricks For Your Next Audit In one […]
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Analysis: DEA Move Could Limit How Pharma Markets Heavy Painkillers
March 27, 2013 A top DEA official sent a letter this week to FDA, encouraging the agency to crack down harder on how pharmaceutical companies are marketing narcotic painkillers to doctors. The letter stated that these types of drugs are involved in many more deaths than heroin and cocaine combined. Some of the proposed changes […]
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Pfizer Settles Dead Dog Lawsuit
Is GSK Pressure on FDA Influencing Hospira 483 Failures? Two years after filing a widely publicized lawsuit, a Colorado couple has reached a settlement with Pfizer over allegations the drugmaker failed to sufficiently warn that its Rimadyl medication, a non-steroidal anti-inflammatory treatment for dogs, can cause severe harm. And now, the couple plans to take […]
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