FDA Ordered to Make Plan B Pills Available
Latest FDA and cGMP Compliance News A federal court this week ruled that the older type of Plan B morning after pills is allowed to be sold to girls and women of all ages on an OTC basis. At the same time, the court state that FDA can also restrict access to the newer, one […]
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Novartis Manufacturing Plant Slammed With Warning Letter
Latest FDA and cGMP Compliance News Novartis CEO Joe Jimenez is fond of saying that quality matters, but FDA does not seem to believe him. Again, FDA has sent the firm a warning letter. This time the matter at hand is the Ebewe Pharma generic injectables plant in Austria. Last year this plant had cGMP […]
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Should FDA Be Holding the Avandia Advisory Committee Meeting?
Latest FDA and cGMP Compliance News This highly controversial agency advisory committee meeting is starting today, but a question remains open – would letting up on the restrictions on the Avandia diabetes pill make a difference? The GSK drug, which has been linked to heart attack and stroke, is pretty much not available on the […]
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J&J Recall Nightmare – 32 Million Boxes of Contraceptives in 43 Countries
Latest FDA and cGMP Compliance News Johnson & Johnson and the term ‘recall’ are becoming one and the same, it seems. The most recent example is the birth control pill Cilest, which has had 32 million boxes pulled in 43 countries. The reason is that the active ingredient dissolves slowly and does not provide the […]
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What Should FDA Do About Ibuprofen?
Latest FDA and cGMP Compliance News A Reuters story recently stated that using ibuprofen in long term, high doses is just as hazardous in terms of cardiac risks as using Vioxx, which was withdrawn from the market due to heart dangers. Reuters was referencing a study that was reported recently in the British medical Journal […]
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FDA Scientists Do Not Find Misconduct in Avandia Trial Data
Latest FDA and cGMP Compliance News A review of clinical trial data on the safety of Avandia did not reveal any fraud or misconduct, according findings by FDA scientists that were posted today on the agency website. These conclusions got a good deal of heat from the FDA scientist who first called foul on the […]
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Lundbeck Slapped with Big Fine in EU for Pay to Delay Deals
Latest FDA and cGMP Compliance News A year after handing down charges to nine pharmaceutical companies, Lunbeck, Merck KGgA and Ranbaxy Laboratories among them, with blocking entry of generic copies of the Celexa antidepressant, the European Commission is going to start giving out fines. In July, the European Commission charged that Lundbeck and several rivals […]
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Hospira Keeps Getting Warning Letters – Is a Consent Decree Coming?
Latest FDA and cGMP Compliance News The executives at Hospira have been collecting warning letters and 483s from FDA like baseball cards the last few years, it seems. Let’s do a count, shall we? In the last year, Hospira received: 4 warning letters, including one just issued to an Indian plant 6 483s 7 more […]
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Rogue FDA Reviewer Insists that ARB Heart Drugs Can Cause Cancer
Latest FDA and cGMP Compliance News We are now seeing another instance of a medical reviewer at FDA clashing with his superiors over drugs known as angiotension receptor blockers. These are taken by 20 million people to help to stop strokes and heart attacks. But, they were linked to a high cancer risk in 2010. […]
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Major cGMP Problems Lead to Drug Shortages
Latest FDA and cGMP Compliance News This week FDA reported that there is a serious shortage of injectable drugs in the area of total parenteral nutrition, which is an intravenous solution that is used to treat infants who can’t eat or drink by mouth yet. The reason for the shortage is that the key supplier […]
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