Warner-Chilcott Sales Reps Allege Fraud
H/T: Pharmalot In one of the more expansive whistleblower lawsuits to be filed against a drugmaker, a pair of former Warner-Chilcott sales reps have detailed numerous means in which they allege fraud was committed in order to boost sales of various prescription drugs. Clearing Up CDRH eCopy Confusion Many of the charges appear familiar – […]
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J&J dropping lubricant products named in FDA warning letter
The website dedicated to Johnson & Johnson’s K-Y sex lubricants is populated by pictures of smiling couples. But in one corner–above the “Foreplay and Massage” link–is a very small link called “K-Y Supply and News.” What it tells those who find it is that Johnson & Johnson is under an FDA order to recall a bunch […]
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FDA smartphone regulation could stifle innovation
US politicians have called on the Food and Drug Administration (FDA) to provide more information about the way it intends to regulate medical smartphone apps, warning the regulator’s draft guidance risks holding back innovation in the sector. Republican leaders of the House Energy and Commerce Committee wrote to FDA commissioner Margaret Hamburg earlier this month […]
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FDA warns Stryker on quality issues, marketing practices
Orthopedic implant maker Stryker Corp said it received a warning letter from the U.S. Food and Drug Administration related to quality concerns at its Portage, Michigan facility. The letter also said Stryker failed to notify the regulator of a product recall, and had been marketing devices without approval. The FDA acknowledged that Stryker has submitted […]
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Nuke the eCopy Confusion and Chaos!
March 14, 2013 CDRH has been requiring eCopy for every submission since Jan. 1. We have been hearing about MANY eCopy holds because of many compliance issues with the new eCopy format. We have heard about issues including: Â File size PDF file format Folder structure Folder naming conventions File naming conventions Also, people are just […]
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AbbVie Sues EMA Over Clinical Trial Data
Clearing the eCopy Confusion! In a direct challenge to the proponents of disclosing clinical trial data, AbbVie has filed a request for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies concerning its top-selling Humira rheumatoid arthritis treatment, The Financial Times writes. Tomorrow – A Classic FDA Auditing Trick […]
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Ghana FDA Reveals Massive Fraud at 3 Pharma Companies
Tomorrow – A Classic FDA Auditor Trick! Ghana FDA recently discovered widespread fraud at three pharmaceutical companies in Ghana – Lymens Medical Supplies Limited and Sarkuff Pharmacy. According to media report, the three firms are alleged to have imported unregistered, fake and poor quality medicines. Clearing the eCopy Confusion! FDA stated that many of these […]
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FDA OCI Division Targeting Pharma Manufacturing Practices
Clearing the eCopy Confusion! After the big meningitis outbreak that occurred last year at NECC, the criminal investigation unit of FDA, OCI, is going to be focusing more on the manufacturing practices of pharmaceutical companies. Tomorrow – A Classic FDA Auditor Trick! According to John Roth, the head of the Office of Criminal Investigations, FDA […]
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Vaccine Outsourcing Carries Big Risks
A Classic FDA Auditing Trick The market for contract manufacturing of vaccines is predicted to swell to $620 million by 2015 as Big Pharma ups outsourcing. But the shift carries risks, as GlaxoSmithKline showed when it filed a lawsuit last week. GlaxoSmithKline ($GSK) is suing Hospira ($HSP) over a vaccine deal gone bad. In 2010 […]
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The World Ends – J&J Recalls K-Y Jelly
A Classic FDA Auditing Trick Countless couples may find it a wee bit more difficult to enjoy intimate moments, thanks to yet another recall from Johnson & Johnson. The healthcare giant, which has recalled countless products over the past three years for a variety of manufacturing and safety issues, has just pulled 2.3 million packages […]
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