by Syneos Health_1 | 10 May, 2019 | 21 Century Cures Act, Consultation, Cures Act, FDA Guidance, Real Word Evidence, Regulatory Grade RWE
This draft FDA guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA...
by Syneos Health_1 | 8 May, 2019 | Cures Act, Real Word Evidence, Real World Research Design, Regulatory Grade RWE, White Paper
In contrast to clinical development, in which the randomized controlled trial (RCT) is the go-to study design, real-world research encompasses a broader array of designs from which to choose. There are retrospective approaches, including database analysis and manual...
by Syneos Health_1 | 11 Dec, 2018 | 21 Century Cures Act, Consultation, Cures Act
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations (21 CFR Parts 50, 312, and 812) to implement a provision of the 21st Century Cures Act (Cures Act). This proposed rule, if finalized, would allow an exception from the requirement...
by Syneos Health_1 | 9 Dec, 2018 | 21 Century Cures Act, Cures Act, FDA Guidance, Real Word Evidence
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them. Among other provisions, the Cures Act...
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 | 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...
