October 2015
In Defense of Stringency: In response to growing public concern with health risks posed by approved drugs, a 2006 landmark report by the Institute of Medicine (IOM) argued that the U.S. Food and Drug Administration (FDA) lacks the unambiguous authority necessary to ensure the safety and efficacy of the country’s medicinal products.
In Defense of Stringency
By Tim Horn
The 21st Century Cures Act’s “Pathway to Crisis” in Drug Safety
By Kenyon Farrow
The FDA’s Concession Conundrum
By Lindsay McKenna and Erica Lessem
The Challenge of Defining HIV Remission
By Richard Jefferys
Improving Regulatory Systems to Address Global TB Drug Access Failures
By Erica Lessem
PrEP: The Pathway to Global Access
By Scott Morgan