Explore the details behind the FDA digital health tools platform set for release in the fall of 2018, an initiative designed to allow health software applications and accompanying new drugs to be approved concurrently, further streamlining the approval process for certain combination products.
Is a suffix that distinguishes biosimilars and other biologic products necessary in adverse event reporting? The US FDA says yes, although to date, nearly every adverse event report received by the FDA have identified biosimilars simply by their brand names.
Stay aware of proposed changes to the existing Medicare Part B average sales price (ASP) payment system. Explore Genetech’s “Market-based Pricing Model”, as well as changes to the existing competitive acquisition program, and the possibility of moving Part B drug coverage to Part D in this essential article.
On September 28, 2018, the US FDA issued new draft guidelines for adaptive clinical trial designs, as well as additional guidance updates. Tap into these important updates, which replace draft guidance issued by the agency in 2010.
This comprehensive study identifies key factors driving change in the channels through which non-prescription/OTC medicines are distributed in Europe (18 main EU markets, plus Norway and Switzerland) and highlights the challenges facing suppliers in an ever-changing market.
This 17-country study finds that continued growth of mobile technologies and e-commerce,combined with a more stable regulatory environment, are driving changes in the European mail order and Internet pharmacy market.
Insurers and a neurologist testifying at a May 16 Senate Finance Committee hearing on the CHRONIC Care Act praised the bill’s telehealth provisions. Committee Chairman Orrin Hatch, R-Utah, says he plans to mark up the bill, which has been under development for two years, this week.
OTC drug firms should offer more digital tools that guide consumers in product purchases, says a health care marketing executive. The American Pharmacists Association suggests firms also strengthen outreach with pharmacists.
RB’s spending on the WebMD-hosted Cold & Flu Tracker app generated an ROI three times greater than traditional digital marketing, says marketing executive Emma Howe. Similar campaigns are gaining momentum, with WebMD and Walgreens launching “Relief Advisor.”
Connected care technologies play an important role in disease prevention, but are still not used as widely as they should be. Philips’ second Future Health Index study surveyed 33,000 participants in 19 countries to compare perceptions and experiences of healthcare users across three areas – access to care, integration of health systems and adoption of connected care technologies.
A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD).
Victoria Hordern and Amy Merrick discuss initiatives in the EU to help app developers navigate the unclear rules on mobile health and explain why engaging patients during product development is key.
Biogen’s chief medical officer says iPhone technology should in future be used for early warning diagnosis of Alzheimer’s Disease. Biogen CMO Alfred Sandrock has told a London neuroscience forum that constraints impeding CNS drug development include the fact diagnosis needs to be done earlier but that barrier could be mitigated in future by digital health solutions such iPhones used as “early warning” diagnostics, notably in Alzheimer’s Disease.
The digitalization of health care has been much talked about over the last decade or so. But activity among the medical device manufacturers and service providers has only just recently accelerated as they start overcoming barriers and resistance to this new way of delivering health care.
> Reckitt Reaps ROI Reward In Geo-Targeted Symptoms App Promoting Mucinex, Delsym > Biogen CMO Notes iPhone’s Potential For Early Detection of Alzheimer’s > Interview: Philips Plugs Into Patient Connectivity
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