Read important industry news from February!
To read the article, simply click on the title.
The European Commission’s new patient information guide on biosimilar medicines repeatedly reassures the public of the drug class’ safety by stressing the European Medicines Agency’s careful regulation of a fast-growing, and still developing market. The officially sanctioned guide, released Jan. 20, begins with history: biosimilars have been used safely in the European Union since 2006 as an alternative to reference biologics. To date, the EC has authorized about two dozen biosimilars, the most recent being Lusdana (insulin glargine) for diabetes mellitus, set to launch in April.
More than seven million patients now benefit from remote monitoring and the use of connected medical devices as an integral part of their care routines, says a new estimate from Berg Insights. Remote monitoring use grew by 44 percent in 2016 as providers and patients rapidly embraced the convenience of mHealth tools. The use of remote monitoring is expected to continue its growth at a compound annual growth rate (CAGR) of 47.9 percent to reach 50.2 million by 2021.
Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration’s (FDA) process for inspecting device manufacturers. Specifically, the bill calls for FDA to implement a more consistent, risk-based inspection process, as well as to improve communications with device makers regarding inspections and findings. “The current device facility inspection process lacks transparency, predictability and consistency between facilities,” Isakson said. “This bill is designed to improve communication and consistency in the device facility inspections process, which will allow both FDA and device manufacturers to make more efficient use of resources.” – See more at: http://www.raps.org/Regulatory-Focus/News/2017/02/21/26926/Senators-Look-to-Overhaul-Medical-Device-Inspections/#sthash.ar6HAzPu.dpuf
The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. EMA says the guideline will consider the data requirements with respect to quality aspects in relation to the safety and performance of the medical device, whether it is an integral component of the medicinal product or a stand-alone device, including usability studies in target patient populations with the relevant clinical conditions. – See more at: http://www.raps.org/Regulatory-Focus/News/2017/02/16/26853/EMA-Weighs-New-Guideline-on-Quality-Requirements-for-Combination-Products/#sthash.3CQc7V6z.dpuf
“If you look at the camera, the flash, the microphone… they all are getting better and better,” said Shwetak Patel, engineering professor at the University of Washington. “In fact the capabilities on those phones are as great as some of the specialized devices,” he told the American Association for the Advancement of Science (AAAS) annual meeting this week. Smartphones can already act as pedometers, count calories and measure heartbeats. But mobile devices and tablets can also become tools for diagnosing illness. “You can use the microphone to diagnose asthma, COPD (chronic obstructive pulmonary disorder),” Patel said. “With these enabling technologies you can manage chronic diseases outside of the clinic and with a non-invasive clinical tool.” Read more at: https://phys.org/news/2017-02-smartphones-revolutionizing-medicine.html#jCp
PathWise White Papers
Read important industry news from January! To read the article, simply click on the title. "The Food and Drug Administration (FDA) recently issued a final guidance titled “Postmarket Management of Cybersecurity in Medical Devices.” The guidance applies to “(1)...