Reagan-Udall Post-Market Drug Surveillance Initiative Could Address Patient Web Sites
This article was originally published in The Pink Sheet Daily
Executive Summary
The IMEDS project getting under way at the Reagan-Udall Foundation could eventually address methods for analyzing data on drug side effects that are available through patient networking sites and blogs, though initial efforts will focus on insurance claims data and electronic medical records.
You may also be interested in...
US FDA Taps Pfizer Executive For CDER Deputy Director Slot
Patrizia Cavazzoni, Janet Woodcock's new #2, has a background similar to Richard Moscicki, CDER's previous deputy director for operations.
FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE
Results from the US Food and Drug Administration’s RCT DUPLICATE demonstration are in. The findings both legitimize certain real-world evidence studies and also highlight the challenges involved in using RWE to replicate randomized clinical trials.
Preapproval Information Exchange Between Sponsors, Insurers Clarified In House User Fee Bill
By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.