Healthcare providers experience the most frequent battery problems with large-volume infusion pumps and would like manufacturers to add green, yellow and red LED lights that change color when the battery status changes.
Researchers from Parion Sciences observed that the salt water spray inhaled while surfing seemed to help clear the lungs of cystic fibrosis patients, so they enlisted the help of Cambridge Consultants to create a nebulizer that aerosolizes salt water.
The FDA has sent an “It Has Come to Our Attention” letter to Biosense Technologies, claiming that it must reapply to market its uChek Urine Analyzer app since the app, which uses testing strips made by Bayer and Siemens, was not indicated in those companies’ marketing applications.
Senator Claire McCaskill (D-Mo.) is taking medical products supply companies to task for misleading senior citizens into ordering medical products that either they don’t need or that don’t come directly from their doctors.
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today.Read More
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!