Blog
RSS FeedPosted by Michael Wonder on 09 Dec 2021
FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...
Posted by Michael Wonder on 29 Nov 2021
FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...
Posted by Michael Wonder on 24 Nov 2021
A vision for use of real world evidence in EU medicines regulation
24 November 2021 - Enabling the use of real world evidence and establishing its value for regulatory decision-making on the development, ...
Posted by Michael Wonder on 24 Nov 2021
Review of real world evidence and patient reported outcomes
24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...
Posted by Michael Wonder on 28 Oct 2021
FDA acknowledges hurdles in utilising real world data
28 October 2021 - FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into ...
Posted by Michael Wonder on 21 Oct 2021
FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data
21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...
Posted by Michael Wonder on 06 Oct 2021
Aetion and NICE announce collaboration to explore use of real world evidence for comparative effectiveness studies to inform clinical guidance
6 October 2021 - Collaboration will leverage the Aetion Evidence Platform to study when and how real world evidence can support ...
Posted by Michael Wonder on 02 Oct 2021
FDA, sponsors advance reliance on real world data & evidence
2 October 2021 - Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional ...
Posted by Michael Wonder on 14 Sep 2021
EMA study reveals need for RWE framework, submission structure
14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...
Posted by Michael Wonder on 31 Aug 2021
Real world outcomes associated with new cancer medicines approved by the FDA and EMA: a retrospective cohort study
August 2021 - Real world data studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice ...
Posted by Michael Wonder on 24 Aug 2021
ICER uses observational real world evidence to update 2018 assessment on therapies for hereditary angioedema, finds therapies far less cost effective than earlier estimates
24 August 2021 - Patients initiating therapy in real world dataset had less frequent baseline attack rates than rates from clinical ...
Posted by Michael Wonder on 11 Aug 2021
‘We don’t unlearn’: what the pandemic has taught regulators about real world data
11 August 2021 - During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to patients. ...
Posted by Michael Wonder on 05 Aug 2021
From Our Perspective: FDA approval demonstrates the role of real world evidence in regulatory decision-making on drug effectiveness
4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination ...
Posted by Michael Wonder on 21 Jul 2021
Fit for purpose real world data assessments in oncology: a call for cross stakeholder collaboration
21 July 2021 - Real world evidence remains a promising frontier in evidence generation to support improved health related patient outcomes. ...
Posted by Michael Wonder on 16 Jul 2021
FDA approves new use of transplant drug based on real world evidence
16 July 2021 - Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a ...