Misbranding Charge Levied on Compounding Pharmacy
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot In 2007, three people in Oregon and Washington quickly died after being administered with injectable colchicine, a treatment for gout. The deaths were attributed to super-potent doses – some vials later tested from the same shipment sent to the clinics where the patients were treated […]
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Ernst & Young Hit With $2 Mil Fine for Pharma Audit Lapses
New Webinar With Highly Detailed FDA 483/WL Data! The watchdog agency for the accounting industry said Wednesday that it has fined big firm Ernst & Young $2 million for alleged lapses in three audits of a pharmaceutical company. The Public Company Accounting Oversight Board said the civil fine against the accounting firm was the largest […]
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Pharma Ties Must Be Disclosed, Docs Say
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot In the midst of ongoing negative publicity and controversy over ties between the medical community and the pharmaceutical industry, a majority of physicians who were surveyed in 2009 reported that they completely agreed with the idea that financial relationships with drugmakers should be disclosed. To […]
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Insider Trading Charge Settled at Takeda for $136,000
Source: Pharmalot Brent Bankosky, the former senior director at Takeda Pharmaceuticals has agreed to pay more than $136,000 to settle charges that he traded on inside information about various business alliances and acquisitions, according to the US Securities and Exchange Commission. New Webinar With Highly Detailed FDA 483/WL Data! Bankosky, who worked at US headquarters […]
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GSK brings work in-house in bid to boost efficiency and cut costs
New Webinar With Highly Detailed FDA 483/WL Data! GSK is bringing outsourced work back in-house and placing manufacturing at existing sites in a bid to boost efficiency.
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Rx Studies Online Have Disorganized and Confusing Side Effect Data, Study States
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot Here is a finding that will likely thrill drugmakers that argue consumers should avoid purchasing their meds over the Internet: a majority of web sites selling cholesterol pills lacked information about contraindications, key warnings and side effects. Moreover, risk information was presented in a “chaotic†[…]
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Bayer Goes to War with Feds On $93 Million Tax Bill
Source: Pharmalot In 1997, a diligent vice president in the Bayer tax department named Paul Wright was reviewing a type of US tax credit the drug and chemical maker had taken in previous years for qualified research expenses and he decided that the US Internal Revenue Service had been incorrect to deny some or all […]
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Major Problems Revealed in FDA 483 For Shuttered Novartis Plant
New Webinar With Highly Detailed FDA 483/WL Data! Novartis 483s and EIR Novartis’ idled plant in Lincoln NE had its FDA inspections conclude on Jan. 20. Now the firm must mull over the extensive 483 findings. The plant was voluntarily closed Dec. 19 to address a multitude of problems that have led to several recalls […]
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FDA warns PhotoMedex, Merit Medical on quality violations
New Webinar With Highly Detailed FDA 483/WL Data! The U.S. health regulator sent warning letters to medical device makers PhotoMedex Inc and Merit Medical Ireland Ltd saying their devices were adulterated and misbranded. In a letter to PhotoMedex dated Jan. 26, the U.S. Food and Drug Administration said the company’s manufacturing of its wound dressing […]
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Obama Administration Takes Sales Reps’ Side in Overtime Dispute
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot The US Solicitor General has filed an amicus curiae, or friend of the court brief, and sided with pharma reps. The move is not surprising, given that the US Department of Labor has, several times, taken a similar step in federal courts around the country […]
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