FDA News & Recalls News

FDA Fast Track

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

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 consumer market. But the program will remain intact, and companies will continue to have a way to fast-track product development without having to go through […]

Aug 12, 2014 Read More...

power morcellation

FDA Pushes for Warning on Power Morcellators, Informed Consent

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 of spreading undetected cancer – a risk that may be more common than previously thought. During a recent two-day meeting, the FDA health advisors concluded […]

Jul 16, 2014 Read More...

The FDA is requiring blood clot warnings on testosterone packages.

FDA Requires Testosterone Drugmakers to Add Blood Clot Warning

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 such as deep vein thrombosis and pulmonary embolism. Product labels already warn of possible clots forming because of a condition called polycythemia, which causes an […]

Jun 23, 2014 Read More...

red blood cells

FDA, Experts Discuss Risks of Newer Blood Thinners

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 the benefits of anticoagulants against excessive bleeding risks is a challenge for medical researchers and clinicians. That’s why the Food and Drug Administration (FDA) and […]

May 19, 2014 Read More...

Generic prescription drugs

Petition Calls on FDA to Hold Makers of Generic Drugs Accountable

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 was to blame. Karen Bartlett took the generic pain pill sulindac for shoulder pain. Within weeks, her skin began peeling off in clumps. Her lungs […]

Apr 30, 2014 Read More...

FDA warning

Inspection Triggers FDA Warning for Mesh Manufacturer

The U.S. Food and Drug Administration (FDA) issued a warning letter to Endo International PLC following an inspection of the pharmaceutical company’s facility in Minnetonka, Minn. According to the FDA, Endo violated three federal regulations governing how it manufactures some of its urological devices. Endo’s Minnesota facility is run by its subsidiary, American Medical Systems […]

Apr 23, 2014 Read More...

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