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  2. >>Geography
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Reagan-Udall Post-Market Drug Surveillance Initiative Could Address Patient Web Sites

 
• By Cathy Kelly

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.

The post-market drug surveillance program getting under way at the Reagan-Udall Foundation could eventually address methods for analyzing data on drug treatment experiences, including side effects, that are increasingly posted through patient networking sites and blogs, according to project manager Troy McCall.

However, McCall pointed out during a Reagan-Udall-sponsored webinar June 6 that the initial focus of the program, known as Innovation...

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More from North America

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 
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