News from the healthcare data industry
Matthew W. Reynolds, Vice President, Real World Solutions, IQVIA 03.09.22Recent FDA guidance on using real world data (RWD) to study the safety and effectiveness of products and treatments represents an exciting advancement for...
March 09, 2022 04:15 PM Eastern Standard Time WASHINGTON–(BUSINESS WIRE)–Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration’s (FDA) recent draft...
Report Prepared by the Oncology Industry Taskforce RWE Working Group, a Medicines Australia Initiative Read the Report here: https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2020/11/OIT-RWE-Report-Oct-2020-FINAL-MA-VERSION.pdf
When Robert Califf became the new commissioner of the U.S. Food & Drug Administration, he did so with a plan to emphasize the use of real-world evidence (RWE) in Agency decisions....
Posted 02 March 2022 | By Mary Ellen Schneider Pharmaceutical manufacturers and patient advocates want to see more details from the US Food and Drug Administration as it finalizes guidance on...
Executive Summary In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do...
February 15, 2022 06:56 AM Eastern Standard Time CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the U.S. Food and Drug Administration (FDA)...
Posted 11 February 2022 | By Joanne S. Eglovitch The US Food and Drug Administration (FDA) should adopt updated data standards that accommodate the “evolving and emerging” nature of real-world data...
Feb 9 (Reuters) – The European Medicines Agency has set up a new centre to collect and mine more public health data from EU member states to improve the review...
Posted 07 February 2022 | By Jeff Craven About one-third of the guidance documents in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER)’s 2022 guidance...