FDA Update: June medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
Japanese pharmaceutical company Daiichi Sankyo recently announced it received a complete response letter (CRL) from the Food and Drug Administration (FDA) for the New Drug Application (NDA) of the cancer-fighting drug quizartinib.
While the long-term effects of treatment with paclitaxel-coated devices in the peripherals are still unclear, the U.S. Food and Drug Administration could not rule out an association with adverse effects, even at very low drug concentrations.
Six drugs were recalled in June to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
The Food and Drug Administration recently approved the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000.
Seven outbreaks of foodborne illnesses have been reported so far this year, according to the U.S. Food and Drug Administration.
Jane Orient, executive director of the Association of American Physicians and Surgeons and president of Doctors for Disaster Preparedness, believes it’s the latest example of chemophobia.
Food producers carried out 46 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
WASHINGTON -- A low percentage of cancer drugs that received accelerated Food and Drug Administration approval had positive results in the long run, according to a recent study by the Journal of the American Medical Association.
Few cancer drugs that received accelerated Food and Drug Administration approval lived up to their billing, according to a JAMA study.
The IB-Stim would be used in combination with other IBS therapies.
A public health watch dog warns that the presence of “forever chemicals” in foods recently tested by the Food and Drug Administration should be treated with alarm.
Five drugs were recalled in May to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
The Food and Drug Administration's (FDA) recently announced a mandatory added sugar labeling policy for packaged foods and beverages, set to take effect between 2020 and 2021.
The U.S. Food and Drug Administration recently approved a drug that costs $2.1 million and it’s a potential cure for a childhood disorder that afflicts children under 2 years of age.
The Food and Drug Administration granted full approval to nearly 800 generic drugs in fiscal year 2018, a 90 percent increase over the same time period four years ago, according to a recent analysis by PricewaterhouseCoopers LLP.
Amyotrophic lateral sclerosis, better known as Lou Gehrig’s disease, is an illness that has no FDA approved drug to alleviate the symptoms. In fact, it does not have a cure.
The U.S. Food and Drug Administration recently sent letters to companies that produce homeopathic products claiming they were in violation of current good manufacturing practice (CGMP) regulations.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration sent letters to companies that produce homeopathic products claiming they were in violation of current good manufacturing practice (CGMP) regulations.