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Senators Urge FDA to Remove Power Morcellators from Device Market

Power Morcellators and Cancer

Two U.S. senators are pressing the Food and Drug Administration (FDA) to pull power morcellators from the market to eliminate the risk of spreading undetected cancer. Democratic Sens. Chuck Schumer [...]

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FDA Tightens 510(k) Program but Fast-Track for Medical Devices Remains

FDA Fast Track

The Food and Drug Administration (FDA) will tighten up the standards of its controversial 510(k) program, narrowing the scope of how medical device makers can take new products to the [...]

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FDA Pushes for Warning on Power Morcellators, Informed Consent

power morcellation

Members of a specially formed Food and Drug Administration panel say there is not enough evidence to prove using power morcellators to remove uterine fibroids does not increase the risk [...]

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FDA Requires Testosterone Drugmakers to Add Blood Clot Warning

The FDA is requiring blood clot warnings on testosterone packages.

The U.S. Food and Drug Administration (FDA) is requiring manufacturers of testosterone replacement drugs to include warnings about the increased risk of blood clots that may develop and cause conditions [...]

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FDA, Experts Discuss Risks of Newer Blood Thinners

red blood cells

Anticoagulants like warfarin and Pradaxa are considered effective treatments for preventing blood clots in people with heart and blood vessel diseases. But the drugs can also cause excessive bleeding. Balancing [...]

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Petition Calls on FDA to Hold Makers of Generic Drugs Accountable

Generic prescription drugs

Gabriel Drapos was a freshman at Harvard when he was diagnosed with ulcerative colitis and had to have his large intestine removed. A generic form of the acne medication Accutane [...]

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