Oncology: The Pathway for New Cancer Drug Access in Canada
Cancer treatment has evolved significantly over the past decade with the emergence of a multitude…
RWE and FDA: Six Years of the US Food and Drug Administration’s Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation
Congress mandated the creation of a postmarket Active Risk Identification and Analysis (ARIA) system containing…
Book: Post-Authorization Safety Studies of Medicinal Products: The PASS Book and Pharmacoepidemiology
Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by…
Book: Pharmacoepidemiology And Therapeutic Risk Management
Pharmacoepidemiology And Therapeutic Risk Management: Hartzema, Abraham G., Tilson, Hugh H., Chan, K. Arnold: 9780929375304:…
RWE and EMA
DARWIN EU delivers real-world evidence from across Europe on diseases, populations and the uses and performance of medicines. …
RWE and FDA
FDA has a long history of using what we currently call real-world data (RWD) and…