Clinical Investigator In FDA Hot Water for Not Opening Mail
When doctors and researchers sign up to participate in a clinical trial, they are expected to do a few basic things. Among them is keeping up to date with the clinical trial doings. One way to accomplish this is to open the mail. But not everyone does. As a result, one investigator was forced to […]
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FDA Debars Doc In Pfizer Research Scandal
Do you remember Scott Reuben? He was accused of faking research for a dozen years in published studies suggesting after-surgery benefits from Vioxx and Celebrex. Last year, he was sentenced to six months in jail plus three years supervised release after pleading guilty to fraud. The former chief of acute pain at Baystate Medical Center […]
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FDA cites 1,200 tobacco retailers
The Food and Drug Administration said Thursday it has issued about 1,200 warning letters to retailers in 15 states for violating federal tobacco regulations since beginning inspections under a 2009 law giving it authority to regulate the industry. The agency’s Center for Tobacco Products, using state contractors, has conducted more than 27,500 inspections of stores […]
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Abbott, A Clinical Trial And A Doctor’s Allegiance
drugmakers that are battling claims a med caused someone harm is to use a doctor as a shield. In legal parlance, this is known as the learned intermediary doctrine, which, basically, states that a drugmaker has fulfilled its responsibility for providing all necessary information to a doctor, who then interacts with a patient. But Abbott […]
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FDA Inspects How Many Clinical Trial Investigators?
Thanks to numerous scandals, the FDA is under mounting pressure to step up its oversight of drug development and manufacturing. But what do the metrics look like? Well, the agency has now released numbers showing its efforts to inspect and audit facilities that are involved in drug development specifically, such as clinical trial investigators and […]
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Merck CEO To Head Penn State Sex Abuse Probe
Fresh off a day in which he courted Wall Street with an increased dividend and pipeline promises, Merck ceo Ken Frazier is now shifting his sights toward college scandals and sexual abuse. The Penn State University Board of Trustees have tapped Frazier to head the investigation into child sex abuse that has turned the school […]
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FDA releases two new draft guidances
The FDA this week issued two new draft guidances and launched a new standard operating protocol for requesting new data from products undergoing pre-market review. In two draft guidances the federal watchdog agency offered new approaches to feasibility studies for products under investigational device exemption and outlined the process for device makers who want to […]
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GlaxoSmithKline sets up $50 mln life sciences fund in Canada
Pharmaceutical major GlaxoSmithKline is setting up a $50 million fund in Canada to invest in early stage research. The GSK Canada Life Sciences Innovation fund will be managed by GSK in Canada and the company’s venture capital division, SR One. “The GSK Canada Life Sciences Innovation Fund will provide a competitive advantage to Canada’s life […]
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No Scrips: Doctor Boycotts Novartis Over Job Cuts
A rheumatologist based in Geneva, Switzerland, says he will no longer prescribe Novartis medicines to patients as a way of protesting jobs cuts and plant closings the drugmaker is undertaking in the country, according to a blog he wrote for La Tribune de Geneve. “My only way of protesting is to go on a prescription […]
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What FDA Letters? Merck Tries To Bury Bad News
Generally, drugmakers will issue a press release after receiving a so-called Complete Response Letter from the FDA. Simply put, these missives indicate that the agency has declined to approve a drug and generally suggest what is needed to make approval happen. This is not the sort of news any drugmaker wishes to tout, but disclosure […]
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