The first drug to treat low sexual desire in women, touted as the “female Viagra,” won approval from the U.S. Food and Drug Administration. The health regulators approved the drug Addyi after twice rejecting the treatment because they did not think the benefits outweighed the drug’s risks, an article in Reuters reports.
Addyi is designed for women with a condition known as hypoactive sexual desire disorder. According to PubMed.gov, ...
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A growing body of evidence seems to suggest that the FDA; the regulatory agency in charge of ensuring that the foods and drugs we ingest will not harm us, may not be as independent as the public may assume them to be.
One of the largest and most publicly visible hits to the agency’s credibility occurred earlier this year when the FDA issued a draft guidance which cleared the way for drug ...
continue reading...Nasdaq.com reports that the U.S. Food and Drug Administration (FDA) has approved Praluent, the first of a new and highly anticipated class of cholesterol medications. The drug, jointly developed by Sanofi SA and Regeneron Pharmaceuticals, will provide an alternative to patients who have not had success with statins like Pfizer’s controversial Lipitor.
From 1996 until its patent expired in 2011, Lipitor was the world’s best-selling drug, with an estimated $125 billion in ...
continue reading...A recent letter from the U.S. Food and Drug Administration (FDA) reveals that IVC maker C. R. Bard committed several quality system violations at its facilities in Queensbury, New York, and Tempe, Arizona. According to the FDA, Bard failed to “establish and maintain procedures for receiving, reviewing, and evaluating complaints as required by [law].” The agency cites several instances in which Bard’s quality system did not ensure adequate evaluation ...
In a July 13 letter, the U.S. Food and Drug Administration (FDA) called out IVC filter maker C. R. Bard on medical device reporting violations. Inspection of the Bard Peripheral Vascular facility in Tempe, Arizona, in late 2014 revealed that Bard failed or refused to submit reports regarding the safety of its IVC Denali Filter Delivery System.
Bard is already in hot water for its allegedly ...
continue reading...In addition to warning IVC filter maker C. R. Bard about medical device reporting and quality system violations, the U.S. Food and Drug Administration (FDA) has also cracked down on two Bard IVC filter recovery devices that have not been cleared for market. In its July 13 letter, the FDA held Bard accountable for adulteration/misbranding violations at its Tempe, Arizona, facility. The charges concern Bard’s ...
