29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...
28 October 2021 - FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into ...
21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...
2 October 2021 - Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional ...
August 2021 - Real world data studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice ...
11 August 2021 - During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to patients. ...
4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination ...
21 July 2021 - Real world evidence remains a promising frontier in evidence generation to support improved health related patient outcomes. ...
16 July 2021 - Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a ...
19 May 2021 - RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. ...
17 March 2021 - U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as ...
16 March 2021 - Among the many ways that the U.S. FDA protects and promotes the public health is by ensuring ...
12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...
12 January 2021 - In alignment with the International Council of Harmonization’s strategic goals, a public private consortium has developed a ...
8 October 2020 - Real world evidence has gained increased attention in recent years as a complement to traditional clinical trials. ...