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FDA doesn’t enforce standards for sterile healthcare products manufacturer
It's impossible for the public to know when regulators first discovered Bacillus cereus at H&P Industry's plant...
Web Exclusive: FDA Approves 3-D Mammography Machine
Radiologists find that images created from the three-dimensional scans are better at detecting cancers and results of...
A bid to expand eligibility for weight-loss surgery
A Food and Drug Administration advisory panel last month recommended allowing doctors to use the Lap-Band, a less...
Cooling caps tested to help cancer patients keep hair
A handful of San Francisco breast cancer patients are donning frigid skullcaps to test a device designed to keep hair...
Web Exclusive: FDA approval of medical devices praised in industry-funded study
The controversial approval process the Food and Drug Administration uses for most medical devices has in fact enjoyed...
J&J recalls hip replacement implant
More than two years after the Food and Drug Administration began receiving complaints about the failure of a hip...
FDA warns J&J on illegal marketing of medical devices
Another day, another Johnson & Johnson news item -- and once again, not a flattering one. The...
Medical device makers pan FDA proposals
Proposed changes to the U.S. system for regulating medical devices are more objectionable to the industry...
FDA moves toward tighter medical device oversight
Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win...
Web Exclusive: FDA Criticized for Unsafe Medical Device Approval Process
Eight serious loopholes and cracks in the U.S. Food and Drug Administration's approval process allow potentially...