Posts Tagged 'FDA approval'

60 Minutes Airs Damning Evidence Against Boston Scientific in Piece on Mesh Claims

60 Minutes airs damaging report on Boston ScienticWith over 100,000 pelvic and other gynecological mesh cases pending in courts around the country, one question that has been on everyone’s mind is much closer to an answer thanks to some investigative reporting that aired earlier this month on CBS’ 60 Minutes.

The question is a simple, yet far-reaching one: what could possibly have gone so wrong with these devices as to cause this level of ...

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FDA Issues Safety Announcement for New Liver Disease Drug

fda issues statement on OcalivaBloomberg reports that the FDA has issued a safety announcement for Intercept’s Ocaliva, a drug designed for a rare liver disease known as primary biliary cholangitis. The announcement comes after at least 19 deaths were attributed to the medication, which was only introduced in May of 2016.

Intercept claims to have explicitly warned doctors of the specificity with which they must prescribe Ocaliva and how it must be taken by patients. ...

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Deal Between FDA, Medical Device Makers Could Put Consumers At Risk

FDA and drug makers renegotiate reporting agreementCongress is planning to vote on a deal between the medical device industry and the FDA that could come at great risk to consumers, according to the New York Times. The agreement between the two parties is renegotiated every five years and focuses heavily on the fees that medical device companies pay the agency to review their products.

The most concerning part of the proposed agreement comes in ...

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Study Discovers Safety Risk in One-third of FDA-approved Drugs

one-third of FDA approved drugs not safeA recent study published in the Journal of the American Medical Association has identified that one-third of FDA-approved drugs carry a safety risk that is found after the medications have already gone to market. It’s a rate that’s both alarming and unexpected from an agency that is supposedly charged with protecting the public’s health.

Joseph Ross, an associate professor of medicine and public health at Yale University and ...

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FDA Approves ‘Female Viagra’ with Strong Warning

FDA approves female viagraThe 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, this condition occurs ...

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Members of Congress: Close FDA loophole

Four Democratic U.S. Representatives have introduced legislation designed to close a major loophole in the process by which the federal Food and Drug Administration approves medical devices. The legislation’s sponsors specifically cite vaginal mesh implants and metal-on-metal hip implants as dangerous and defective devices that have made it onto the market as a result of that loophole.

A news release from the bill’s main sponsor, ...

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