Ranbaxy Drugs Are Declared Safe in Australia
Latest FDA and cGMP Compliance News In a major boost to the embattled generic drug manufacturer, the drug regulatory authority in Australia declared that the drugs made by Ranbaxy Laboratories are safe. The Australian Therapeutics Goods Administration (TGA) said this week that there is not any evidence that the drug products in Australia made by […]
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Where Is Big Pharma Hiring These Days?
Latest FDA and cGMP Compliance News We always hear about consolidation in the drug industry, as well as many stories about layoffs that are coming. But some pharmaceutical companies are still hiring. Of course, priorities do shift as projects in the industry change, so it does mean that some drugmakers are looking for good […]
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FDA Inspections Set to Spike in India
Latest FDA and cGMP Compliance News FDA has recently pointed out that there have been a large number of cGMP violations in India noted in 483s and warning letters. Therefore, FDA reported this week that foreign cGMP audits are going to spike as the number of FDA registered drug plants outside the US are increasing. […]
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FDA Rejects New Merck Sleeping Pill – For Time Being
Latest FDA and cGMP Compliance News In a major set back for Merck, FDA has turned down a sleeping pill that Wall Street thinks will someday generate over $700 million in sales each year. FDA issued a response letter to Merck, which was published this week. The major issue is the one of dosing, which […]
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Glaxo Employees Held in China on Graft Probe
Latest FDA and cGMP Compliance News GlaxoSmithKline last month told the media that there was an internal investigation occurring to investigate an allegation that some of its sales team in China was bribing physicians to prescribe certain drugs. Now Chinese authorities are detaining three GSK employees, and one of them is a senior finance executive, […]
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FDA Drops the Hammer – 1677 Online Pharmacies Closed
Latest FDA and cGMP Compliance News Consumers may find the prices tempting, but ordering prescription drugs from an online pharmacy can be risky, and FDA this week took action. It has shut down 1677 websites that were selling counterfeit or poor quality drugs. Many other sites have gotten regulatory warnings from FDA. FDA officials noted […]
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Medical Device CEO HELD HOSTAGE in China
Latest FDA and cGMP Compliance News The CEO of a medical device company in Florida is being held hostage at his firm’s factory in Beijing since June 21. His captors? His own employees. The name of the CEO is Chip Starnes, and the firm is Specialty Medical Devices. The problem started when severance packages were […]
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Intuitive Surgical Blasted in 483 for Not Reporting Warning
Latest FDA and cGMP Compliance News FDA stated this week in a 483 to Intuitive Surgical that the firm broke mandatory cGMP regulations when it warned customers about problems with its da Vinci surgical robot without telling regulators first. According to the recently released 483, between Jan. 2010 and Dec. 2011, the firm had 134 […]
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India Cancels J&J Plant License
Latest FDA and cGMP Compliance News In another big blow to the efforts by Johnson & Johnson to improve its reputation after many cGMP manufacturing issues, the government in western India is upholding a recent decision to cancel J&J’s license to make cosmetics in a factory in Mumbai. In March, the Indian FDA cancelled the […]
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DTC Drug Ad Text Is Too Hard to Read, Group Says
Latest FDA and cGMP Compliance News We all have heard the expression that you need to read the fine print. And there is always a lot of fine print in many of the print ads for pharmaceutical products. But is that text too small for people to read? Many people who take the drugs are […]
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