by chuck_ltd | 30 Mar, 2018 | 21 Century Cures Act, Cures Act, EHR, Real Word Evidence, Virtual Clinical Research
The Trump Administration is launching the MyHealthEData initiative which aims to empower patients by ensuring that they control their healthcare data and can decide how their data is going to be used, all while keeping that information safe and secure CMS is committed...
by chuck_ltd | 3 Apr, 2017 | 21 Century Cures Act, Cures Act, EU Clinical Trials Regulation, Pragmatic Trials
It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting...
by chuck_ltd | 12 Feb, 2017 | 21 Century Cures Act, Consultation, FDAMA114, Uncategorized
18 January 2017 – the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications...
by chuck_ltd | 19 Jan, 2017 | CHCUK News & Articles, Cures Act, EAP, News
The landmark 21st Century Cures Act[1] (“Cures Act”), which was signed into law by President Obama and became effective on December 13, 2016 (“Enactment Date”), imposes a deadline by which the manufacturer or distributor of an investigational...
by chuck_ltd | 12 Jan, 2017 | CHCUK News & Articles, News
On Dec. 13, President Obama signed into law the 21st Century Cures Act (Cures). The goal was to “accelerate the discovery, development and delivery” of innovative products, including by adding and modifying various programs administered by the Food and Drug...