A smart card-enabled Cholesterol Monitor will be available to consumers by year-end pending FDA approval, the Post Falls, Idaho-based company says. The device uses one drop of blood to determine cholesterol levels in three minutes; the results are then encrypted and downloaded on the included Privalink Microsoft Smart Card for Windows, allowing them to be sent to doctors or pharmacists via the Internet; the data also can be delivered in person. Other software records cholesterol levels for later review. Print advertising and an infomercial will promote the product to consumers and professionals, who must cooperate in establishing an information system to receive and store the data. The monitor will retail for $129.95, with packets of six test kits selling for $19.95
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
