Latest Aleve PM Copy Could Have 180-Day Exclusivity From More Competition

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.

At a recent plenary session the European Parliament adopted a resolution calling on the European Commission to “conduct a new and comprehensive assessment” of the impact of the revised Urban Wastewater Treatment Directive on the pharmaceutical sector.