European Medicines Agency boosts EU transparency
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The European Medicines Agency has begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. FDA approves generic versions of blood thinner Plavix
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The U.S. Food and Drug Administration approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries. FDA issues alert on potential dangers of unproven treatment for multiple sclerosis
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The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called "liberation therapy" or the "liberation procedure" to treat chronic cerebrospinal venous insufficiency (CCSVI). FDA approves first Boniva generics to treat or prevent osteoporosis
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The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause. FDA announces safety changes in labeling for some cholesterol-lowering drugs
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Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration. FDA acts to bolster supply of critically needed cancer drugs
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The U.S. Food and Drug Administration announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama's Executive Order to help prevent future drug shortages. European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections
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The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate. More Pharma News ...
- FDA approves first generic version of cholesterol-lowering drug Lipitor
- Drug not Shown to be Safe and Effective in Breast Cancer Patients
- European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs
- European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix
- European Medicines Agency completes its review of Avastin used in breast cancer
- FDA begins process to remove breast cancer indication from Avastin label
- European Medicines Agency and ENCePP launch electronic Register of Studies