US FDA Portal Open To Receive OTC Monograph Meeting Requests

The evidence underpinning the “polluter pays” principle of the revised Urban Wastewater Treatment Directive - which calls on Europe's pharmaceutical industry to cough up at least 80% of the cost of updating wastewater treatment facilities - is looking increasingly shaky, according to a new report.

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.