by Stuart McCully | 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 Stuart McCully | 8 May, 2019 | 21 Century Cures Act, HTA, Real Word Evidence, Registry
REQueST® tool and its Vision paper are now available for Public Consultation The use of registries is becoming increasingly common in health technology assessment (HTA) and regulation. There is a growing interest in the role of observational data in complementing...
by Stuart McCully | 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 Stuart McCully | 9 Dec, 2018 | 21 Century Cures Act, FDA Guidance, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Grade RWE
It’s here! The long awaited FDA “draft framework for implementation” of the real world evidence program required by Section 3022 of The 21st Century Cures Act (Cures Act) has been published. Framework for FDA’s Real World Evidence Program The Cures Act is...
by Stuart McCully | 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 Stuart McCully | 19 Nov, 2018 | 21 Century Cures Act, CHCUK News & Articles, Consultation, Real Word Evidence, Registry, Regulatory Grade RWE
Use of patient disease registries for regulatory purposes (new) On 8 November 2018 the EMA cross-committee task force published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes:...
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 | 27 Jul, 2017 | 21 Century Cures Act, CHCUK News & Articles, Pragmatic Trials, Real Word Evidence
FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv...
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...
