Ranbaxy Plans to Chop Hundreds of Jobs
Latest FDA and cGMP Compliance News As if Ranbaxy Laboratories does not have enough trouble, it looks like more is on the way. The embattled generic manufacturer of pharmaceuticals is in the process of cutting as many as 400 jobs from many divisions, such as R&D and finance, as well as various API units. […]
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SEC Charges Insider Trading at Onyx Pharmaceuticals
Latest FDA and cGMP Compliance News About one week after word got out that Onyx Pharmaceuticals turned down a $10 billion offer from Amgen, the SEC filed a suit claiming that several people had committed insider trading and made almost $5 million in illegal profits on an investment of about $300,000. The traders, who are […]
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FDA Sends Nasty Warning Letter to Honey Company
Latest FDA and cGMP Compliance News Did you ever think that a jar of honey could be construed to be a drug? If you promote honey for treating allergies and arthritis, as far as the FDA says, you are saying that your honey is a drug and it is going to need to be approved […]
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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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